Clinical trial NCT05299723: The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Official title: A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Acute Coronary Syndrome
Keywords: sleep
light therapy
chronotherapy
circadian
cardiovascular
insomnia
short sleep duration
intervention
acute coronary syndrome
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

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 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).

Primary outcomes:
measure: Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion
timeFrame: At end of 4-week intervention period
measure: Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility
timeFrame: At end of 4-week intervention period
measure: Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability
timeFrame: At end of 4-week intervention period
measure: Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep
timeFrame: At end of 4-week intervention period
measure: Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability
timeFrame: At end of 4-week intervention period
measure: Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period
timeFrame: At end of 4-week intervention period
measure: Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period
timeFrame: At end of 4-week intervention period
measure: Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period
timeFrame: At end of 4-week intervention period
measure: Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period
timeFrame: At end of 4-week intervention period
Secondary outcomes:
measure: Difference in the Total Score of Insomnia Severity Index
timeFrame: Baseline, 4 weeks
measure: Difference in the Total Global Score of Pittsburgh Sleep Quality Index
timeFrame: Baseline, 4 weeks
measure: Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4).
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: CUIMC
state: New York
Study officials:
affiliation: Associate Professor of Medical Sciences
name: Ari Shechter, PhD
role: PRINCIPAL_INVESTIGATOR
References: