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NCT Number: NCT05701969

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Virginia

Charlottesville, Virginia, 22908-0710, United States

Location status: Recruiting

Location contact

Keita Ikeda, PhD

CONTACT

[email protected]

9195931174

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

Melatonin

Placebo

Other

Placebo control

Primary outcomes

  1. Total Sleep Time (TST)

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

Secondary outcomes

  1. Light Sleep

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

  2. Deep Sleep

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

  3. Rapid Eye Movement Sleep

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

  4. Latency to Persistent Sleep (LPS)

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

  5. Wake after Sleep Onset (WASO)

    Time frame: 2 weeks

    Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

  6. Sleep Efficiency (SE)

    Time frame: 2 weeks

    monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

Other outcomes

  1. Epworth Sleepiness Scale

    Time frame: 2 weeks

    Score 0-24 (Interpretation:

    0-7: Unlikely to be abnormally sleepy. 8-9: Average amount of daytime sleepiness.

    10-15: May be excessively sleepy depending on the situation. Consider seeking medical attention.

    16-24: Excessively sleepy, consider seeking medical attention.)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Chuang, MA

CONTACT

[email protected]

7575348912

Keita Ikeda, PH.D.

CONTACT

[email protected]

9195931174

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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