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NCT05349188 · ClinicalTrials.gov registry record · Phase 1
Feasibility Study of Personalized Trials to Improve Sleep Quality
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05349188 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 60 participants.
The verdict
NCT05349188, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg of melatonin, and the final bottle containing a placebo pill. The first two weeks will be a baseline period, where no supplement is assigned, but data are collected, including self-report of sleep quality and duration and accelerometer-derived sleep and activity data. After successful completion of the baseline period, participants will be randomized to six 2-week intervention blocks of a 3 mg dose melatonin, a 0.5 mg dose melatonin, and a placebo. At the end of the trial, participants will be asked to complete the System Usability Scale, a satisfaction survey (electronic or phone/video call if they are non-responders), and participate in a virtual interview (such as over Microsoft Teams or a phone call) to inform feasibility and acceptability of protocol requirements, study materials, and personalized reports.
Interventions
- DIETARY_SUPPLEMENT Melatonin 3 mg
- DIETARY_SUPPLEMENT Melatonin 0.5 mg
- OTHER Cellulose placebo pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-05-11 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05349188
The ClinicalTrials.gov registry entry for NCT05349188 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Melatonin 3 mg is the first listed.
NCT05349188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05349188 about?
NCT05349188 is a clinical study titled "Feasibility Study of Personalized Trials to Improve Sleep Quality". The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg o...
What is the current status of trial NCT05349188?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-05-11. Estimated completion is 2023-05-22.
What interventions are being tested in trial NCT05349188?
The interventions under investigation include: Melatonin 3 mg (DIETARY_SUPPLEMENT), Melatonin 0.5 mg (DIETARY_SUPPLEMENT), Cellulose placebo pill (OTHER).
Who is sponsoring clinical trial NCT05349188?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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