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NCT05701969 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift
A Early Phase 1 study, sponsored by University of Virginia.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT05701969 is a Early Phase 1 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 50 participants.
The verdict
NCT05701969, a Early Phase 1 study, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep. Previous studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and time spent in deep and rapid eye movement (REM) sleep were significantly reduced during night float and did not return to baseline after 3 nights of recovery. Melatonin is a hormone produced by the pineal gland, which regulates the circadian rhythm that governs sleep. Exogenous melatonin may be used as a sleep aid and is available over the counter in the United States. Melatonin is effective in realigning the circadian rhythm disorder caused by night shift work and increasing sleep duration; however, melatonin's effect on improving sleep in resident trainees has not been investigated. The investigators propose a prospective double-blinded randomized control trial to investigate the effect of melatonin on sleep quantity and quality in resident physicians assigned to a night float system.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-05-30 |
| Est. Completion | 2028-06-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05701969
The ClinicalTrials.gov registry entry for NCT05701969 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05701969 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05701969 about?
NCT05701969 is a clinical study titled "Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift". Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep. Previous studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and tim...
What is the current status of trial NCT05701969?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2022-05-30. Estimated completion is 2028-06-30.
What interventions are being tested in trial NCT05701969?
The interventions under investigation include: Placebo (OTHER), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05701969?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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