Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID05701969

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

Led by University of Virginia · Updated on 2026-05-04

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of melatonin on sleep patterns in resident physicians working night float shifts. The study focuses on residents in various specialties including anesthesiology, general surgery, obstetrics and gynecology, general medicine, and pediatrics. Night float shifts are known to reduce total sleep quantity and quality, especially deep and REM sleep, and melatonin is being studied for its potential to help realign circadian rhythms and improve sleep in this setting. Participants will be randomly assigned to receive either 3 mg of melatonin or a matching placebo during two separate night float periods with at least two weeks between them. They will take one capsule at least 20 minutes before sleep or after completing their night shift for a 12-day period each time. The study includes baseline sleep monitoring for 2-3 nights, 5-6 nights during night float, and 3-4 nights of recovery, using a portable EEG device to record detailed sleep data. Throughout the study, participants will wear the EEG monitor to track sleep stages such as light sleep, deep sleep, and REM sleep, along with measures like total sleep time, sleep efficiency, and wake after sleep onset. They will also complete daily questionnaires on daytime sleepiness and stimulant use. Data collected will compare sleep quality and quantity during melatonin and placebo weeks to assess the impact of melatonin on resident sleep during night float shifts.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Post-Graduate Year 1 to 5
  • Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the University of Virginia
Not Eligible

You will not qualify if you...

  • Current use of sleep aids
  • Diagnosed sleep disorder
  • History of a pacemaker or other medical device
  • Pregnant or breastfeeding females
  • Bleeding disorders
  • Depression
  • High blood pressure
  • Seizure disorders
  • History of transplant on immunosuppression therapy
  • None specified beyond these criteria for healthy volunteers inclusion/exclusion limitations in the source data

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility assessment

Treatment

Duration - 12 consecutive days per treatment period

Participants take either melatonin or a placebo daily during their night float week while wearing a portable EEG monitor to track sleep patterns.

1 baseline period of 2-3 nights, 5-6 nights during night float, and 3-4 nights recovery per treatment period; two treatment periods separated by at least 2 weeks

Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908-0710

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Research Team

K

Keita Ikeda, PH.D.

E

Emily Chuang, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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