← Back to Search

Hormone Therapy

Melatonin for Sleep Wake Disorders

Phase < 1
Led By Lauren Dunn, MD PHD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will study how melatonin affects sleep quality and quantity for doctors on night shift to help improve their performance.

Who is the study for?
This trial is for resident trainees in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics at the University of Virginia. Eligible participants are those in their first five years post-graduation who aren't using sleep aids or have a history of certain medical conditions like bleeding disorders, depression, high blood pressure, seizures, or are pregnant.Check my eligibility
What is being tested?
The study tests if melatonin improves sleep quantity and quality among residents working night shifts compared to a placebo. It's a double-blinded randomized control trial meaning neither the researchers nor participants know who receives melatonin or the inactive substance (placebo).See study design
What are the potential side effects?
Melatonin may cause side effects such as morning grogginess, vivid dreams or nightmares. Some people might also experience small changes in blood pressure and body temperature.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Sleep Time (TST)
Secondary outcome measures
Deep Sleep
Latency to Persistent Sleep (LPS)
Light Sleep
+3 more
Other outcome measures
Epworth Sleepiness Scale

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Daytime drowsiness
Blurred vision
Study treatment Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Melatonin groupExperimental Treatment1 Intervention
These subjects will receive melatonin
Group II: Placebo groupPlacebo Group1 Intervention
These subjects will receive placebo
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,023 Total Patients Enrolled
Lauren Dunn, MD PHDPrincipal InvestigatorUniversity of Virginia

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05701969 — Phase < 1
Circadian Rhythm Disorder Research Study Groups: Melatonin group, Placebo group
Circadian Rhythm Disorder Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05701969 — Phase < 1
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701969 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have recruitment efforts for this trial begun yet?

"Affirmative. The clinical trial, which first appeared on May 30th 2022 and was last amended on January 18th 2023, is in search of 50 participants from 1 site according to the information provided by ClinicalTrials.gov."

Answered by AI

What is the current enrollment rate for this research study?

"Affirmative. According to data published on clinicaltrials.gov, this medical trial is currently enrolling participants - with the initial posting occurring on May 30th 2022 and the most recent update taking place January 18th 2023. 50 patients must be recruited from a single centre for this study."

Answered by AI
~4 spots leftby Jun 2024