Breast Cancer
Conditions
Brief summary
This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.
Detailed description
The purpose of this pilot study is to evaluate the feasibility of implementing a home-based, personalized bright light intervention, and to estimate the effects of bright light on 4 common long-term or late effects of cancer (sleep disturbance, fatigue, depression, cognitive dysfunction) and on quality of life in post-treatment survivors of breast cancer. The three specific aims include: Aim #1: To assess the feasibility of implementing a home-based, personalized bright light intervention and the proposed data collection plan in post-treatment survivors of breast cancer. Aim #2: To estimate the effects of the personalized bright light intervention on sleep disturbance, fatigue, depression, cognitive dysfunction, and quality of life in survivors of breast cancer. Aim #3: To estimate the effects of a personalized bright light intervention on circadian rhythms in survivors of breast cancer. The participants of this randomized, controlled pilot study will be randomized to either 30-minute blue-green light therapy at 12,000 lux or dim red light control at 5 lux. Light will be self-administered using a light visor cap at home for 14 consecutive days. Tailored to the individual's circadian pattern, light will be delivered either within 30 minutes of waking in the morning or between 1900-2000 hours in the evening. The nocturnal sleep patterns will be monitored by all-night in-lab polysomnography; sleep quality, fatigue, depression, and quality of life will be self-reported; cognition will be objectively assessed before and after the intervention. Circadian rhythm will be indexed by nocturnal core body temperature before and after the intervention. Feasibility will be determined by the proportion of contacted, recruited, and retained subjects, and completeness of the data collected. Subjective feedback and burden will be assessed at study exit.
Interventions
DIAGNOSTIC_TESTPolysomnography (PSG)
Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.
DIAGNOSTIC_TESTRectal thermistor 400 Series
Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.
OTHERBright blue-green light
-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
OTHERDim red light
-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
DIAGNOSTIC_TESTDigital foot candle datalogging light meter
On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1 x 2.9 x 1.0 light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.
8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.
OTHERPatient-Reported Outcomes Measurement Information System (PROMIS)-Depression
8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84 PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.
OTHERPatient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function
8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores means more the attribute to be measures: e.g., for fatigue, sleep disturbance, depression, higher scores mean worse fatigue, worse sleep disturbance, worse depression. But for physical function, higher scores mean better functioning.
19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.
OTHERCenter for Epidemiological Studies - Depression
20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.
The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.
OTHEREuropean Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.
OTHERDaily Log
-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue & sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness
Sponsors
National Institute of Nursing Research (NINR)
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Females * 21 years of age or older 1-3 years post-completion of chemotherapy or/and radiation therapy for stage I-III breast cancer * Experience ≥ 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments) * Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ) ≥59 or ≤41) * Sighted * Mentally competent to consent * Able to understand English.
Exclusion criteria
* Undergoing cancer treatment for another malignancy * Have metastatic cancer * Engaged in shift work or travel across more than three time zones within 2 weeks prior to study * Current diagnosis of seasonal affective disorder or substance abuse Current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies * Report severe depressive mood (Center for Epidemiological Studies Depression Scale (CES-D) \>24) * Take prescribed sedative hypnotics or steroids Have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Attrition and Adherence | Up to 3 weeks from registration | Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Pittsburgh Sleep Quality Index (PSQI) Global score: The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality. |
| Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score. A higher PROMIS-Cancer-Fatigue T-score represents greater\\worse fatigue. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse fatigue Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average. |
| Effects of Bright Light on Fatigue as Measured by the Daily Log | Kept throughout the approx 3 weeks of the study | Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue |
| Effects of Bright Light on Depression as Measured by the PROMIS-Depression | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score. A higher PROMIS-Depression T-score represents greater\\worse Depression. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse worse depression. Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average. |
| Effects of Bright Light on Depression as Measured by the CES-D | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed. |
| Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction. |
| Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score. A higher PROMIS-Physical Function T-score represents greater\\better Physical Function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean better functioning. Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average. |
| Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life |
| Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score. A higher PROMIS-Sleep disturbance T-score represents greater\\worse sleep disturbance. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse sleep disturbance Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of latency to sleep onset is reported. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Minutes of awakenings during sleep is recorded. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Arousal minutes during sleep are recorded |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Arousal index is total number of arousals per hour of sleep. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes till wake after sleep onset is reported. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) used to measure effects of bright light on level of stress. Minutes spent in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Percentage of time in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage. |
| Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported. |
Countries
United States
Participant flow
Pre-assignment details
10 participants withdrew prior to assignment for: schedule coordination issues (n=8); loss of contact after 3 attempts (n=2)
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Bright Blue-green Light * Bright blue-green light (\
515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details | 15 |
| Arm 2: Dim Red Light -Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Headache after intervention | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Arm 2: Dim Red Light | Arm 1: Bright Blue-green Light |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 14 Participants | 15 Participants |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 8.4 | 54.2 years STANDARD_DEVIATION 8.7 | 50.8 years STANDARD_DEVIATION 8.1 |
| Chronotype Eveningness | 8 Participants | 4 Participants | 4 Participants |
| Chronotype Morningness | 22 Participants | 11 Participants | 11 Participants |
| Education | 16.1 years STANDARD_DEVIATION 2.7 | 16.5 years STANDARD_DEVIATION 2.6 | 15.6 years STANDARD_DEVIATION 2.7 |
| Employment Full time | 19 Participants | 10 Participants | 9 Participants |
| Employment Part time | 2 Participants | 1 Participants | 1 Participants |
| Employment Retired | 4 Participants | 3 Participants | 1 Participants |
| Employment Self employed | 5 Participants | 1 Participants | 4 Participants |
| Living Arrangement Lives alone | 3 participants | 2 participants | 1 participants |
| Living Arrangement Lives with others | 27 participants | 13 participants | 14 participants |
| Marital Status Divorced | 7 Participants | 4 Participants | 3 Participants |
| Marital Status Married/Partnered | 20 Participants | 9 Participants | 11 Participants |
| Marital Status Single | 2 Participants | 1 Participants | 1 Participants |
| Marital Status Widowed | 1 Participants | 1 Participants | 0 Participants |
| Number of Comorbidities 0 | 13 participants | 6 participants | 7 participants |
| Number of Comorbidities 1 | 8 participants | 3 participants | 5 participants |
| Number of Comorbidities 2 | 6 participants | 3 participants | 3 participants |
| Number of Comorbidities 3 or more | 2 participants | 3 participants | 0 participants |
| Previous Treatment Both (chemotherapy & radiation) | 9 participants | 4 participants | 5 participants |
| Previous Treatment Chemotherapy | 3 participants | 1 participants | 2 participants |
| Previous Treatment Radiation | 18 participants | 10 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 14 Participants | 14 Participants |
| Region of Enrollment United States Greater Lansing, Michigan | 22 Participants | 11 Participants | 11 Participants |
| Region of Enrollment United States St Louis Metro., Illinois/Missouri | 8 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tumor Stage Stage I | 19 participants | 11 participants | 8 participants |
| Tumor Stage Stage II | 8 participants | 3 participants | 5 participants |
| Tumor Stage Stage III | 3 participants | 1 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Study Attrition and Adherence
Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention
Time frame: Up to 3 weeks from registration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: Bright Blue-green Light | Study Attrition and Adherence | Attrition | 1 Participants |
| Arm 1: Bright Blue-green Light | Study Attrition and Adherence | Adherence to light therapy | 14 Participants |
| Arm 2: Dim Red Light | Study Attrition and Adherence | Attrition | 1 Participants |
| Arm 2: Dim Red Light | Study Attrition and Adherence | Adherence to light therapy | 14 Participants |
Secondary
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Global | 65.6 score on a scale | Standard Deviation 16.6 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Global | 76.2 score on a scale | Standard Deviation 7.9 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Symptom | 20.7 score on a scale | Standard Deviation 13 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Symptom | 13.4 score on a scale | Standard Deviation 7.1 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Function | 76.7 score on a scale | Standard Deviation 15.7 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Function | 87.0 score on a scale | Standard Deviation 6.6 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Function | 80.4 score on a scale | Standard Deviation 10.4 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Global | 76.1 score on a scale | Standard Deviation 16 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Symptom | 12.1 score on a scale | Standard Deviation 7.3 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Global | 81.0 score on a scale | Standard Deviation 11 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Post-Test QOL-Function | 87.6 score on a scale | Standard Deviation 9.2 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | Baseline QOL-Symptom | 19.5 score on a scale | Standard Deviation 9 |
Secondary
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function
Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score. A higher PROMIS-Physical Function T-score represents greater\\better Physical Function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean better functioning. Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | Baseline | 47.5 T-score | Standard Deviation 10.2 |
| Arm 1: Bright Blue-green Light | Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | Post-Test | 48.7 T-score | Standard Deviation 9.2 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | Baseline | 48.6 T-score | Standard Deviation 8.1 |
| Arm 2: Dim Red Light | Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | Post-Test | 51.3 T-score | Standard Deviation 8.3 |
Secondary
Effects of Bright Light on Depression as Measured by the CES-D
Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Depression as Measured by the CES-D | Baseline | 14.7 score on a scale | Standard Deviation 8.3 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Depression as Measured by the CES-D | Post-Test | 6.0 score on a scale | Standard Deviation 3.8 |
| Arm 2: Dim Red Light | Effects of Bright Light on Depression as Measured by the CES-D | Baseline | 16.3 score on a scale | Standard Deviation 4.1 |
| Arm 2: Dim Red Light | Effects of Bright Light on Depression as Measured by the CES-D | Post-Test | 8.9 score on a scale | Standard Deviation 5.3 |
Secondary
Effects of Bright Light on Depression as Measured by the PROMIS-Depression
Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score. A higher PROMIS-Depression T-score represents greater\\worse Depression. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse worse depression. Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Depression as Measured by the PROMIS-Depression | Baseline | 50.4 T-score | Standard Deviation 7.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Depression as Measured by the PROMIS-Depression | Post-Test | 45.2 T-score | Standard Deviation 5.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Depression as Measured by the PROMIS-Depression | Baseline | 51.1 T-score | Standard Deviation 6.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Depression as Measured by the PROMIS-Depression | Post-Test | 46.5 T-score | Standard Deviation 7 |
Secondary
Effects of Bright Light on Fatigue as Measured by the Daily Log
Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue
Time frame: Kept throughout the approx 3 weeks of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Fatigue as Measured by the Daily Log | Baseline self-reported fatigue | 3.54 score on a scale | Standard Deviation 2.03 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Fatigue as Measured by the Daily Log | Post-Test self-reported fatigue | 1.92 score on a scale | Standard Deviation 1.44 |
| Arm 2: Dim Red Light | Effects of Bright Light on Fatigue as Measured by the Daily Log | Baseline self-reported fatigue | 4.57 score on a scale | Standard Deviation 2.41 |
| Arm 2: Dim Red Light | Effects of Bright Light on Fatigue as Measured by the Daily Log | Post-Test self-reported fatigue | 2.86 score on a scale | Standard Deviation 2.35 |
Secondary
Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score. A higher PROMIS-Cancer-Fatigue T-score represents greater\\worse fatigue. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse fatigue Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | Baseline | 55.8 T-score | Standard Deviation 6.8 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | Post Test | 48.3 T-score | Standard Deviation 4.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | Baseline | 56.3 T-score | Standard Deviation 7.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | Post Test | 50.5 T-score | Standard Deviation 6.4 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Arousal index is total number of arousals per hour of sleep.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | Baseline | 8.4 Total number of arousals per hr of sleep | Standard Deviation 3.5 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | Post-Test | 7.8 Total number of arousals per hr of sleep | Standard Deviation 2.8 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | Baseline | 9.6 Total number of arousals per hr of sleep | Standard Deviation 5.3 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | Post-Test | 8.1 Total number of arousals per hr of sleep | Standard Deviation 4 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Arousal minutes during sleep are recorded
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | Baseline | 53.4 minutes | Standard Deviation 20.4 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | Post-Test | 45.8 minutes | Standard Deviation 17.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | Baseline | 64.6 minutes | Standard Deviation 40.7 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | Post-Test | 58.0 minutes | Standard Deviation 32.2 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Minutes of awakenings during sleep is recorded.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | Baseline | 20.5 minutes | Standard Deviation 8.6 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | Post-Test | 15.6 minutes | Standard Deviation 5.2 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | Baseline | 16.4 minutes | Standard Deviation 7.1 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | Post-Test | 15.2 minutes | Standard Deviation 6 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency
Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | Baseline | 81.9 percentage of sleep time | Standard Deviation 7.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | Post-Test | 81.0 percentage of sleep time | Standard Deviation 14.3 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | Baseline | 82.7 percentage of sleep time | Standard Deviation 8.08 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | Post-Test | 82.4 percentage of sleep time | Standard Deviation 12.2 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of latency to sleep onset is reported.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | Baseline | 58.6 minutes | Standard Deviation 64.8 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | Post-Test | 35.7 minutes | Standard Deviation 33.1 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | Baseline | 43.9 minutes | Standard Deviation 49.5 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | Post-Test | 52.4 minutes | Standard Deviation 55.4 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Percentage of time in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 1 | 6.9 percentage of sleep time | Standard Deviation 4 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 1 | 6.7 percentage of sleep time | Standard Deviation 2.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 2 | 60.6 percentage of sleep time | Standard Deviation 10.7 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 2 | 64.8 percentage of sleep time | Standard Deviation 7.7 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 3 | 9.2 percentage of sleep time | Standard Deviation 9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 3 | 7.3 percentage of sleep time | Standard Deviation 7.5 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline REM | 23.4 percentage of sleep time | Standard Deviation 5.4 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test REM | 21.2 percentage of sleep time | Standard Deviation 5.8 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test REM | 20.7 percentage of sleep time | Standard Deviation 6.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 1 | 7.4 percentage of sleep time | Standard Deviation 4.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 3 | 8.5 percentage of sleep time | Standard Deviation 6.6 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 1 | 6.3 percentage of sleep time | Standard Deviation 3.3 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline REM | 23.2 percentage of sleep time | Standard Deviation 6.5 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Baseline Stage 2 | 61.0 percentage of sleep time | Standard Deviation 7.7 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 3 | 6.4 percentage of sleep time | Standard Deviation 8.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | Post-Test Stage 2 | 66.7 percentage of sleep time | Standard Deviation 11 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Objective testing using in-lab polysomnography (PSG) used to measure effects of bright light on level of stress. Minutes spent in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline REM | 93.9 minutes | Standard Deviation 30.7 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 2 | 236.7 minutes | Standard Deviation 49.1 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 1 | 26.0 minutes | Standard Deviation 12.6 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 2 | 250.3 minutes | Standard Deviation 61.3 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test REM | 84.0 minutes | Standard Deviation 28.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 3 | 37.7 minutes | Standard Deviation 40 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 1 | 24.7 minutes | Standard Deviation 7.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 3 | 27.1 minutes | Standard Deviation 30.2 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 3 | 23.4 minutes | Standard Deviation 27.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline REM | 91.7 minutes | Standard Deviation 28.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test REM | 86.5 minutes | Standard Deviation 33.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 1 | 28.2 minutes | Standard Deviation 13.9 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 1 | 26.1 minutes | Standard Deviation 14.5 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 2 | 241.2 minutes | Standard Deviation 55.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Post-Test Stage 2 | 279.9 minutes | Standard Deviation 74.3 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | Baseline Stage 3 | 32.5 minutes | Standard Deviation 23.4 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | Baseline | 394.2 minutes | Standard Deviation 68.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | Post-Test | 386.1 minutes | Standard Deviation 84.8 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | Baseline | 393.53 minutes | Standard Deviation 59.35 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | Post-Test | 415.9 minutes | Standard Deviation 71.5 |
Secondary
Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)
Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes till wake after sleep onset is reported.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | Baseline | 51.6 minutes | Standard Deviation 19.9 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | Post-Test | 72.8 minutes | Standard Deviation 41.5 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | Baseline | 47.8 minutes | Standard Deviation 22.7 |
| Arm 2: Dim Red Light | Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | Post-Test | 48.2 minutes | Standard Deviation 31.4 |
Secondary
Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score. A higher PROMIS-Sleep disturbance T-score represents greater\\worse sleep disturbance. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse sleep disturbance Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | Baseline | 56 T-score | Standard Deviation 6 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | Post-Test | 49.6 T-score | Standard Deviation 5.3 |
| Arm 2: Dim Red Light | Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | Baseline | 57.3 T-score | Standard Deviation 7.5 |
| Arm 2: Dim Red Light | Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | Post-Test | 50.4 T-score | Standard Deviation 6 |
Secondary
Effects of Bright Light on Sleep Disturbance as Measured by the PSQI
Pittsburgh Sleep Quality Index (PSQI) Global score: The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | Baseline | 9.3 score on a scale | Standard Deviation 3.2 |
| Arm 1: Bright Blue-green Light | Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | Post-Test | 7.8 score on a scale | Standard Deviation 2.4 |
| Arm 2: Dim Red Light | Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | Baseline | 9.6 score on a scale | Standard Deviation 3.2 |
| Arm 2: Dim Red Light | Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | Post-Test | 6.0 score on a scale | Standard Deviation 3.1 |
Secondary
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA
MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.
Time frame: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Bright Blue-green Light | Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | Baseline | 27.9 score on a scale | Standard Deviation 1.7 |
| Arm 1: Bright Blue-green Light | Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | Post-Test | 28.0 score on a scale | Standard Deviation 2 |
| Arm 2: Dim Red Light | Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | Baseline | 26.6 score on a scale | Standard Deviation 2.2 |
| Arm 2: Dim Red Light | Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | Post-Test | 27.1 score on a scale | Standard Deviation 1.7 |