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

Primary Purpose

Sleep Disorders, Circadian Rhythm

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin group

Placebo group

Arm Description

These subjects will receive melatonin

These subjects will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Light Sleep
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Deep Sleep
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Rapid Eye Movement Sleep
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
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)
Wake after Sleep Onset (WASO)
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Sleep Efficiency (SE)
monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)

Full Information

First Posted
January 6, 2023
Last Updated
October 18, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05701969
Brief Title
Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift
Official Title
Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
The research pharmacy will randomize the study.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin group
Arm Type
Experimental
Arm Description
These subjects will receive melatonin
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
These subjects will receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
Melatonin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo control
Primary Outcome Measure Information:
Title
Total Sleep Time (TST)
Description
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 Outcome Measure Information:
Title
Light Sleep
Description
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Title
Deep Sleep
Description
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Title
Rapid Eye Movement Sleep
Description
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Title
Latency to Persistent Sleep (LPS)
Description
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Title
Wake after Sleep Onset (WASO)
Description
Measured in hours and fraction of hours, with a portable electroencephalography monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Title
Sleep Efficiency (SE)
Description
monitor ZMachine© Insight+ monitor (General Sleep Corporation, Euclid, OH)
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Epworth Sleepiness Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keita Ikeda, PH.D.
Phone
9195931174
Email
ki2d@uvahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Chuang, MA
Phone
7575348912
Email
QGZ2TK@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Dunn, MD PHD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keita Ikeda, PhD
Phone
919-593-1174
Email
ki2d@uvahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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