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

NCT05701969 | Recruiting Early Phase 1

• 1 other identifier: HSR210118
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Light Sleep

  2 weeks

• Deep Sleep

  2 weeks

• Rapid Eye Movement Sleep

  2 weeks

• Latency to Persistent Sleep (LPS)

  2 weeks

• Wake after Sleep Onset (WASO)

  2 weeks

Other Outcomes (1)

• Epworth Sleepiness Scale

  2 weeks

Study Arms (2)

Melatonin group

EXPERIMENTAL

These subjects will receive melatonin

Dietary Supplement: Melatonin

Placebo group

PLACEBO COMPARATOR

These subjects will receive placebo

Other: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

Melatonin

Melatonin group

Placebo OTHER

Placebo control

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-Graduate Year 1-5
• Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908-0710, United States

RECRUITING

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lauren Dunn, MD PHD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keita Ikeda, PH.D.

CONTACT

9195931174; ki2d@uvahealth.org

Emily Chuang, MA

CONTACT

7575348912; QGZ2TK@uvahealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The research pharmacy will randomize the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: May 30, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)