Investigating melatonin's effects on sleep for resident trainees during night shifts
Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift
This study is testing if melatonin can help resident trainees get better sleep while working night shifts.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05701969 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of melatonin on the sleep patterns of resident trainees working night float shifts in various medical specialties. Participants will be randomized to receive either melatonin or a placebo, with their sleep monitored using portable EEG devices over a 12-day period. The study will assess changes in sleep quality and quantity, particularly focusing on deep sleep and REM sleep, to determine if melatonin can effectively improve sleep during demanding night shifts.
Who should consider this trial
Good fit: Ideal candidates include residents in their first to fifth year of training in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics at the University of Virginia.
Not a fit: Patients currently using sleep aids, diagnosed with sleep disorders, or having certain medical conditions such as high blood pressure or depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to enhance sleep quality for medical residents, potentially improving their overall performance and well-being.
How similar studies have performed: Previous studies have shown that melatonin can effectively realign circadian rhythms and improve sleep quality in shift workers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Post-Graduate Year 1-5 * Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia Exclusion Criteria: * Current use of sleep aids * Diagnosed sleep disorder * History of a pacemaker or other medical device. * pregnant or breast-feeding females * Bleeding disorders * Depression * High blood pressure * Seizure disorders * History of transplant on immunosuppression therapy.
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Dunn, MD PHD — University of Virginia
- Study coordinator: Keita Ikeda, PH.D.
- Email: ki2d@uvahealth.org
- Phone: 9195931174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.