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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: Recruiting Early Phase 1 study, sponsored by University of Virginia.
NCT05701969 is a Early Phase 1 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 50 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
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 |
What NCT05701969 shows while recruiting
NCT05701969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05701969 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05701969's enrollment target sits among peer trials
50 493rd of 2000 higher than 1,468 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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