N/A
N=19
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Sleep Disturbance · Insomnia · Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05299723 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion — 4; 7; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BLT Intervention (Behavioral); BLB Intervention (Behavioral); Sleep Hygiene Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion |
4; 7; 5 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility |
4; 5; 0 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability |
2; 4; 0 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep |
3; 2; 0 | — |
| PRIMARY Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability |
4; 7; 0 | — |
| PRIMARY Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period |
4; 7; 0 | — |
| PRIMARY Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period |
4; 5; 0 | — |
| PRIMARY Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period |
4; 8; 0 | — |
| PRIMARY Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period |
4; 7; 0 | — |
| SECONDARY Difference in the Total Score of Insomnia Severity Index |
-8.25; -5.7; -3.0 | — |
| SECONDARY Difference in the Total Global Score of Pittsburgh Sleep Quality Index |
-5; -3.6; -3.2 | — |
| SECONDARY Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4). |
1; 1; 0.3 | — |
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.
Eligibility Criteria
Patients will be eligible for PHASE A if they meet the following criteria
Inclusion Criteria
- 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.
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 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;
- 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).
Data sourced from ClinicalTrials.gov (NCT05299723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.