Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05701969
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Sleep Disorders, Circadian Rhythm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Melatonin — DIETARY_SUPPLEMENT
    Melatonin
  • Placebo — OTHER
    Placebo control

Study Details

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.

Key Dates

Start date
May 30, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Melatonin group
    These subjects will receive melatonin
  • Placebo Comparator: Placebo group
    These subjects will receive placebo

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908-0710
Keita Ikeda, PhD
[email protected]
9195931174

Find similar trials in Charlottesville, VA

By research site
University of Virginia· Charlottesville, VA

Related Studies