Recruiting
Early Phase 1

Melatonin

Sponsor:

University of Virginia

Code:

NCT05701969

Conditions

Sleep Disorders, Circadian Rhythm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Melatonin

Placebo

Study Details

Brief 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.

Conditions

Sleep Disorders, Circadian Rhythm

Study ID

NCT05701969

Start date

May 30, 2022

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Melatonin group

These subjects will receive melatonin

placebo comparator: Placebo group

These subjects will receive placebo

Interventions

Melatonin

Melatonin

Placebo

Placebo control

Primary outcome measure

  • Total Sleep Time (TST) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908-0710

Contacts

More Information

Sponsor

University of Virginia

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-05-04.