Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Residents in Post-Graduate Years 1-7 enrolled in residency programs with a night float system (anesthesiology, general surgery, obstetrics and gynecology, general medicine, and pediatrics) will be invited to participate in the study. A clinical study coordinator will assist in obtaining informed consent. After informed consent is obtained, participants will be randomized to receive either 3 mg melatonin or a matching placebo control. Medications will be prepared and randomization performed by the University of Virginia Pharmacy. Both participants and study coordinators will be blinded to the treatment group. Participants will be provided with a 12-day supply of medication at the start of the night float week. They will be instructed to take one capsule at least 20 minutes prior to going to bed at night or during the day after completing their night float shift. Subjects will be given a portable electroencephalography (EEG) monitor (ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH))12 and will be shown how to apply the machine, monitor its functionality, and troubleshoot minor issues. They will be asked to wear the device for 2-3 nights of baseline sleep, 5-6 days of sleep during night float, and 3-4 nights of recovery following night float, for a total of 12 consecutive days. Baseline sleep data will serve as a control for each subject. EEG data collected will include: Light Sleep, Deep Sleep, REM, Arousals, Total Sleep Time, Sleep Efficiency, Latency to Persistent Sleep, Wake After Sleep Onset, Total Deep Sleep, Total REM Sleep, and Time Out of Bed. Data from two different night float periods separated by at least 2 weeks will be collected (one-week melatonin and one-week placebo in random order). Residents will also be asked to complete a daily questionnaire assessing daytime sleepiness (Epworth Sleepiness Scale) and the use of caffeine or other stimulants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05701969
Study type Interventional
Source University of Virginia
Contact Keita Ikeda, PH.D.
Phone 9195931174
Email ki2d@uvahealth.org
Status Recruiting
Phase Early Phase 1
Start date May 30, 2022
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05991453 - Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial N/A
Withdrawn NCT05096130 - Lifestyle Medicine Strategies for Combating Sleepiness and Fatigue in Professional Drivers N/A
Completed NCT01327040 - Light Sensitization Study N/A
Completed NCT00593736 - Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome Phase 2
Recruiting NCT00387179 - Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders N/A
Recruiting NCT04900675 - Bright Light Intervention to Reduce Students' Stress N/A
Completed NCT01881854 - Sleep Wake and Melatonin Pattern in Craniopharyngioma N/A
Completed NCT00246051 - Comprehensive Police Fatigue Management Program N/A
Recruiting NCT04690504 - Validation of Circadian Biomarkers in Patients With Sleep Disorders
Completed NCT03363529 - ROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards N/A
Completed NCT00723580 - Actigraphic Analysis of Treatment Response N/A
Completed NCT00207285 - Sleep Disorders Management, Health and Safety in Police N/A
Not yet recruiting NCT06336525 - Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
Recruiting NCT05618405 - Changes in Circadian Rhythm After Anaesthesia in Children
Completed NCT05684523 - Feasibility Study on the Use of Redormin®500 on Day-time Cognition Phase 4
Recruiting NCT05247125 - The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Interventional) Phase 4
Completed NCT04219566 - Vestibular Nerve Stimulation to Improve Sleep N/A
Not yet recruiting NCT06181110 - Sleep-Wake Patterns on Illness Trajectories and Treatment Response in MDD N/A
Not yet recruiting NCT06233422 - Longitudinal Ecological Study on Sleep-Wake Patterns in MDD Using Actigraphy