Sleep Disorders, Circadian Rhythm Clinical Trial
Official title:
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 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Epworth Sleepiness Scale | Score 0-24 (Interpretation:
0-7: Unlikely to be abnormally sleepy. 8-9: Average amount of daytime sleepiness. 10-15: May be excessively sleepy depending on the situation. Consider seeking medical attention. 16-24: Excessively sleepy, consider seeking medical attention.) |
2 weeks | |
Primary | Total Sleep Time (TST) | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Light Sleep | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Deep Sleep | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Rapid Eye Movement Sleep | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Latency to Persistent Sleep (LPS) | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Wake after Sleep Onset (WASO) | Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks | |
Secondary | Sleep Efficiency (SE) | monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH) | 2 weeks |
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