NCT05299723Completed
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
A Pilot Chronotherapeutic Intervention to Improve Sleep Following Acute Coronary Syndrome: The SleepWell Study
Source: ClinicalTrials.gov · Last updated 7 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 15 Mar 2022
- Start date
- 18 Apr 2022
- Primary completion date
- 27 Feb 2024
- Lead sponsor
- Columbia University
- Diseases
- Coronary artery disease
- NCT number
- NCT05299723
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 18 Apr 2022 to the primary completion date, 27 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- taking any anti-depressant or anti-anxiety medications; and
- taking other medications that increase sensitivity to light (by self-report).
Other illness
- 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);
- 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);
- 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);
- 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);
Other
- Non-English speaking;
- Lack of reliable phone or e-mail access;
- Blindness;
- Night shift work schedules;
- Non-English and non-Spanish speaking;
- Lack of reliable phone or e-mail access;
- Blindness;
- Night shift work schedules;
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Patients will be eligible for PHASE A if they meet the following criteria
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CUIMC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.