The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Completed · Not applicable
Conditions studied: Sleep Disturbance, Insomnia, Acute Coronary Syndrome
In brief
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.
Key facts
- Study ID
- NCT05299723
- Run by
- Columbia University
- People needed
- 19
- Starts
- 2022-04-18
- Expected to finish
- 2024-06-26
- Last updated by the study team
- 2025-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older,
- can write, speak and read English,
- provider and patient confirmed ACS,
- ACS event occurred within the past 3 months, and
- 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.
You may not qualify if…
- severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
- 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);
- 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);
- Non-English speaking;
- Lack of reliable phone or e-mail access;
- History of bipolar disorder (manic episode can be triggered by BLT) or positive screen for bipolar disorder based on the Mood Disorder Questionnaire;
- Eye disease including glaucoma or retinopathy (BLT contraindications);
- Blindness;
- Night shift work schedules;
- taking any anti-depressant or anti-anxiety medications; and
- 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:
- 18 years of age or older,
- can write, speak and read English or Spanish,
- provider and patient confirmed ACS,
- ACS event occurred within the past 3 months, and
- 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:
- severe disabling chronic medical and/or psychiatric comorbidities determined on a case-by-case basis that prevent safe or adequate participation;
- 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);
- 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);
- Non-English and non-Spanish speaking;
- Lack of reliable phone or e-mail access;
- History of bipolar disorder (manic episode can be triggered by BLT) or positive screen for bipolar disorder based on the Mood Disorder Questionnaire;
Where it is running
- CUIMC — New York, New York, United States
Full record on ClinicalTrials.gov
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