Sleep Disturbances
Conditions
Keywords
light, circadian rhythms, dim light melatonin onset, sleep
Brief summary
In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later
Detailed description
We will recruit 50 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 2-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.
Interventions
OTHERBlue light
After a two week baseline collection period, half of the subjects will initially be given light masks that deliver blue light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that blue light exposure will delay the timing of the CBTmin.
OTHERRed light
After a two week baseline collection period, half of the subjects will initially be given light masks that deliver red light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that red light exposure will have no effect on the timing of the CBTmin.
Sponsors
University of North Carolina
Rensselaer Polytechnic Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Enrolled participants will be randomized to receive either the active intervention or placebo intervention and then crossed over to receive the opposite intervention. The study consisted of two intervention periods of 8 weeks separated by a two week washout period.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age 65 or older * cognitively capable * able to respond to study staff verbally and in English * score greater than 6 using the Pittsburgh Sleepiness Quality Index * suffer from insomnia * suffer from excessive daytime sleepiness
Exclusion criteria
* Severe sleep apnea * Severe restless leg syndrome (RLS) * Significant cognitive impairment * History of severe photosensitivity dermatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance | Baseline (week 0) and week 8 of lighting intervention | Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome. |
| Total Sleep Time | baseline week (week 0) and the last week of intervention (week 8) | The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome |
| Sleep Efficiency | baseline week (week 0) and the last week of intervention (week 8) | The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data. |
| Sleep Start Time | baseline week (week 0) and the last week of intervention (week 8) | Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data |
Countries
United States
Participant flow
Pre-assignment details
46 participants were enrolled into the study. These participants were randomized to begin the study with the active intervention, or the placebo intervention. After a 2 week washout period, participants were exposed to the opposite intervention.
Participants by arm
| Arm | Count |
|---|---|
| Active Intervention, Then Placebo Intervention Participants started the study by wearing the blue mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the red mask every night for 8 weeks | 24 |
| Placebo Intervention, Then Active Intervention Participants started the study by wearing the red mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the blue mask every night for 8 weeks. | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (8 Weeks) | Withdrawal by Subject | 4 | 6 |
| Second Intervention (8 Weeks) | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Active Intervention, Then Placebo Intervention | Placebo Intervention, Then Active Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| early awakening insomnia | 24 Participants | 22 Participants | 46 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 | 7 Participants | 7 Participants | 14 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 | 17 Participants | 15 Participants | 32 Participants |
| Region of Enrollment United States | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 13 / 34 | 12 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Sleep Disturbance
Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome.
Time frame: Baseline (week 0) and week 8 of lighting intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light Mask | Sleep Disturbance | -1.9 units on a scale | Standard Deviation 0.5 |
| Red Light Mask | Sleep Disturbance | -1.3 units on a scale | Standard Deviation 0.5 |
Primary
Sleep Efficiency
The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.
Time frame: baseline week (week 0) and the last week of intervention (week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light Mask | Sleep Efficiency | 1.3 percentage of sleep | Standard Deviation 2.9 |
| Red Light Mask | Sleep Efficiency | -0.6 percentage of sleep | Standard Deviation 4.7 |
Primary
Sleep Start Time
Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data
Time frame: baseline week (week 0) and the last week of intervention (week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light Mask | Sleep Start Time | 9 minutes | Standard Deviation 21 |
| Red Light Mask | Sleep Start Time | 1 minutes | Standard Deviation 3 |
Primary
Total Sleep Time
The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome
Time frame: baseline week (week 0) and the last week of intervention (week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light Mask | Total Sleep Time | 4 minutes | Standard Deviation 22 |
| Red Light Mask | Total Sleep Time | 1 minutes | Standard Deviation 19 |