The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS

A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05299723

Enrollment

Registered

2022-03-29

Start date

2022-04-18

Completion date

2024-06-26

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Insomnia, Sleep Disturbance

Keywords

sleep, light therapy, chronotherapy, circadian, cardiovascular, insomnia, short sleep duration, intervention, acute coronary syndrome

Brief summary

This two-phase pilot study will test the feasibility of a combined chronotherapy (CC) intervention consisting of morning bright light therapy (BLT) and evening blue light blocking (BLB), administered daily for 4 weeks in patients who experienced acute coronary syndrome (ACS). Phase A of the study will be a single-arm open-label study of the home-based CC intervention in 5 post-ACS patients. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which 15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. In Phase A and Phase B, the primary aims are study feasibility, acceptability, appropriateness, and usability. In Phase B, the investigator will additionally assess whether the intervention engages its proposed proximal target mechanism - sleep.

Detailed description

Survivors of acute medical events often experience psychological distress including post-traumatic stress disorder (PTSD). The goal of this project is to conduct preliminary testing of a chronotherapeutic intervention targeting disturbed sleep in survivors of ACS. There are many ways to try and improve sleep. Some of these include taking medications or working with a trained sleep specialist. The goal of this research study is to investigate the usefulness of a new way of trying to improve sleep (an intervention) that does not involve taking medications or working with a specialist or therapist. Chronotherapeutic interventions are non-pharmacologic approaches that target the circadian or sleep-wake cycle to improve behavioral or health outcomes. Light is the strongest external signal for the human circadian system and manipulations of the light environment (e.g., morning bright light exposure and evening light avoidance) are effective in improving sleep and mood. Participants in Phase A of this study will be asked to use a light visor to administer light to the eye each morning (BLT component of the CC) and orange-colored glasses to block out short wavelength (blue) light to the eye each night before going to bed (BLB component of the CC) for 4 weeks. Participants are also asked to wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. Participants will also receive a sleep hygiene education by watching educational videos. In Phase B of the study, participants will be randomized to either the active CC intervention condition (consisting of both the BLT and BLB components along with sleep hygiene education) or a sleep hygiene education only control condition. Participants will be randomized in a 2:1 ratio to CC condition or control condition. All participants (i.e., those in the CC and control groups) will wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. There will also be a 3 month follow up after the end of the 4-week intervention period for both groups where we assess sleep outcomes.

Interventions

BEHAVIORALBLT Intervention

BLT will be administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.

BEHAVIORALBLB Intervention

BLB will be administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.

BEHAVIORALSleep Hygiene Education

The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

This will be a two-phase pilot study. Phase A of the study will be a single-arm open-label study of the home-based CC intervention in n=5 post-ACS patients. Please note that as Phase A is a single-arm open-label study, there will be no randomization of participants. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which n=15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. The Allocation scheme below refers to Phase B.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients will be eligible for PHASE A if they meet the following criteria Inclusion Criteria: 1. 18 years of age or older, 2. can write, speak and read English, 3. provider and patient confirmed ACS, 4. ACS event occurred within the past 3 months, and 5. presence of insomnia symptoms based on the Insomnia Symptoms Questionnaire, or frequently (3-4 times per week) or always (5-7 times per week) experiencing short sleep duration of 6 hours or less per night.

Exclusion criteria

1. severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation; 2. deemed unable to comply with the protocol (either self-selected or indicated during screening that s/he/they could not complete all requested tasks). This includes, but is not limited to, patients with a level of cognitive impairment indicative of dementia, patients with current alcohol or substance abuse, and patients with severe mental illness (e.g., schizophrenia); 3. unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as we have migrant or mobile patients due to their citizenship and work issues); 4. Non-English speaking; 5. Lack of reliable phone or e-mail access; 6. History of bipolar disorder (manic episode can be triggered by BLT) or positive screen for bipolar disorder based on the Mood Disorder Questionnaire; 7. Eye disease including glaucoma or retinopathy (BLT contraindications); 8. Blindness; 9. Night shift work schedules; 10. taking any anti-depressant or anti-anxiety medications; and 11. taking other medications that increase sensitivity to light (by self-report). Patients will be eligible for PHASE B if they meet the following criteria: Inclusion Criteria: 1. 18 years of age or older, 2. can write, speak and read English or Spanish, 3. provider and patient confirmed ACS, 4. ACS event occurred within the past 3 months, and 5. presence of insomnia symptoms based on the Insomnia Symptoms Questionnaire, or frequently (3-4 times per week) or always (5-7 times per week) experiencing short sleep duration of 6 hours or less per night.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period	At end of 4-week intervention period	Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period	At end of 4-week intervention period	Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period	At end of 4-week intervention period	Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period	At end of 4-week intervention period	Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion	At end of 4-week intervention period	The total number of participants who complete all endpoint questionnaire assessments will be documented and the proportion of participants who fully complete outcome assessments will be computed.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility	At end of 4-week intervention period	Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the FIM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability	At end of 4-week intervention period	Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Acceptability of Intervention Measure (AIM). The AIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the AIM can range from 4 to 20, with higher scores indicating greater acceptability of the intervention.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep	At end of 4-week intervention period	Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the IAM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.
Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability	At end of 4-week intervention period	Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the System Usability Scale (SUS). The SUS is a 10-item questionnaire with a 5-point Likert scale (1= strongly disagree to 5 = strongly agree). The score is calculated by subtracting 1 from each question's raw score then using the following equation: SUS = 2.5 (20 + \[sum of scores on SUS1, SUS3, SUS5, SUS7, SUS9\] - \[sum of scores on SUS2, SUS4, SUS6, SUS8, SUS10\]). The SUS total score can range from 0 to 100, with higher scores indicating better system usability of the intervention.

Secondary

Measure	Time frame	Description
Difference in the Total Global Score of Pittsburgh Sleep Quality Index	Baseline, 4 weeks	This is to measure the baseline-to-study conclusion change in global sleep quality. The Pittsburgh Sleep Quality Index is a 19-item questionnaire that is completed by the participant. The score range is 0-21. Higher score indicates poorer sleep quality. A cutoff value of a total score \> 5 is often used to indicate the presence of poor sleep quality.
Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4).	Baseline, 4 weeks	This is to measure the baseline-to-study conclusion change in self-reported sleep duration (hours spent asleep). Participants enter a value as a whole number in response to the question: During the past month, how many hours of actual sleep did you get at night? (This may be different than the number of hours you spend in bed.)
Difference in the Total Score of Insomnia Severity Index	Baseline, 4 weeks	This is to measure the baseline-to-study conclusion change in insomnia symptom severity. The range of values is 0-28, with higher values indicating worsened severity of insomnia symptoms. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Phase A - Open Label Single-arm All Phase A participants randomized to the CC intervention used a light visor to administer bright light therapy in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for blue light blocking at night from 8:00 pm until going to sleep (BLB). BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock. BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment. Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).	4
Phase B - Active CC Treatment For all Phase B participants randomized to the active CC group, BLT occured each morning after awakening and lasted for 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received a sleep hygiene education. BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock. BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment. Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).	10
Phase B - Sleep Hygiene Education Control Group All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period. Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).	5
Total	19

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	0	2	0

Baseline characteristics

Characteristic	Phase A - Open Label Single-arm	Phase B - Active CC Treatment	Phase B - Sleep Hygiene Education Control Group	Total
Age, Continuous	63.5 years STANDARD_DEVIATION 6.8	60.9 years STANDARD_DEVIATION 13.1	54.4 years STANDARD_DEVIATION 17.3	59.7 years STANDARD_DEVIATION 13.1
Baseline Insomnia Severity Index score	14 units on a scale STANDARD_DEVIATION 6.2	11.4 units on a scale STANDARD_DEVIATION 6.9	19.2 units on a scale STANDARD_DEVIATION 3.4	13.5 units on a scale STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	3 Participants	2 Participants	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	6 Participants	3 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) Black or African American	2 Participants	3 Participants	2 Participants	7 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	1 Participants	4 Participants	0 Participants	5 Participants
Region of Enrollment United States	4 participants	10 participants	5 participants	19 participants
Sex: Female, Male Female	0 Participants	2 Participants	2 Participants	4 Participants
Sex: Female, Male Male	4 Participants	8 Participants	3 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 8	0 / 5
other Total, other adverse events	0 / 4	2 / 8	0 / 5
serious Total, serious adverse events	0 / 4	0 / 8	0 / 5

Outcome results

Primary

Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion

The total number of participants who complete all endpoint questionnaire assessments will be documented and the proportion of participants who fully complete outcome assessments will be computed.