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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: Completed NA study, sponsored by Columbia University.

NCT05299723 is a NA study that has completed, run by Columbia University. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The total number of participants who complete all endpoint questionnaire assessments will be documented and the proportion of participants who fully complete outcome assessments will be computed.

Interventions

  • BEHAVIORAL Sleep Hygiene Education
  • BEHAVIORAL BLT Intervention
  • BEHAVIORAL BLB Intervention

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2022-04-18
Est. Completion 2024-06-26
Phase NA
Columbia University

958 total trials

What the finished NCT05299723 record still lists

NCT05299723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Sleep Hygiene Education is the first listed.

NCT05299723 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05299723's enrollment target sits among peer trials

19 1861st of 2000 higher than 138 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05299723, the US trial registry maintained by the National Library of Medicine. NCT05299723 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.