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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Post-Graduate Year 1-5

Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the Unversity of Virginia

Disqualifiers

Current use of sleep aids

Diagnosed sleep disorder

History of a pacemaker or other medical device.

pregnant or breast-feeding females

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Dietary supplement

    Melatonin

  • Placebo

    Other intervention

    Placebo control

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Melatonin groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
2 weeks

Secondary outcomes

1

Light Sleep

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

Time frame
2 weeks
2

Deep Sleep

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

Time frame
2 weeks
3

Rapid Eye Movement Sleep

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

Time frame
2 weeks
4

Latency to Persistent Sleep (LPS)

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

Time frame
2 weeks

Other outcomes

1

Epworth Sleepiness Scale

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.)

Time frame
2 weeks

Sponsors and contacts

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