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NCT05299723 · ClinicalTrials.gov registry record · NA
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT05299723 is a NA study that has completed, run by Columbia University. The registered enrollment target is 19 participants.
The verdict
NCT05299723, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Sleep Hygiene Education
- BEHAVIORAL BLT Intervention
- BEHAVIORAL BLB Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-04-18 |
| Est. Completion | 2024-06-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05299723
The ClinicalTrials.gov registry entry for NCT05299723 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sleep Hygiene Education is the first listed.
NCT05299723 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05299723 about?
NCT05299723 is a clinical study titled "The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS". 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 ...
What is the current status of trial NCT05299723?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2022-04-18. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT05299723?
The interventions under investigation include: Sleep Hygiene Education (BEHAVIORAL), BLT Intervention (BEHAVIORAL), BLB Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05299723?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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