The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS

NCT ID: NCT05299723

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2024-06-26

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.

Conditions

Sleep Disturbance; Insomnia; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Phase A - open label single-arm

All Phase A participants randomized to the home-based CC intervention will be use a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and use orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).

Group Type: EXPERIMENTAL

BLT Intervention

Intervention Type: BEHAVIORAL

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.

BLB Intervention

Intervention Type: BEHAVIORAL

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.

Sleep Hygiene Education

Intervention Type: BEHAVIORAL

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).

Phase B - active CC treatment

For all Phase B participants randomized to the active CC group, BLT will occur each morning after awakening and will last 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 will also receive a sleep hygiene education.

Group Type: EXPERIMENTAL

BLT Intervention

Intervention Type: BEHAVIORAL

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.

BLB Intervention

Intervention Type: BEHAVIORAL

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.

Sleep Hygiene Education

Intervention Type: BEHAVIORAL

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).

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.

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type: BEHAVIORAL

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).

Interventions

BLT 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.

Intervention Type: BEHAVIORAL

BLB 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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Bright light therapy intervention; Blue light blocking intervention

Eligibility 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.

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.

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:

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 and non-Spanish 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ari Shechter

Assistant Professor of Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ari Shechter, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Medical Sciences

Locations

CUIMC

New York, New York, United States

Countries

United States

References

Mendieta M, Cumella R, Fray N, Lopez-Veneros D, Hiti D, Franqui C, D'Agostino C, Kronish IM, Shechter A. Combined Chronotherapy for Poor Sleep Following Acute Coronary Syndrome: A Pilot Randomized Trial. J Circadian Rhythms. 2025 Feb 25;23:1. doi: 10.5334/jcr.250. eCollection 2025.

Reference Type: DERIVED

PMID: 40028185 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P30AG064198-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU0150

Identifier Type: -

Identifier Source: org_study_id