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Hormone Therapy

Melatonin for Sleep Wake Disorders

Q: Have recruitment efforts for this trial begun yet?

<p>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.</p>

Q: What is the current enrollment rate for this research study?

<p>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.</p>

Phase < 1

Recruiting

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

Timeline

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

Do I qualify?Apply below to find out

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

Recent research and studies

clinicaltrials.govStudy

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

Lauren Dunn, MD 2022. "Effect of Melatonin on Sleep Patterns of Resident Trainees During Night Float Shift". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701969.

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