50 Participants NeededMy employer runs this trial

Melatonin for Sleep Wake Disorders

KI
KI
EC
Overseen ByEmily Chuang, MA
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Virginia
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if melatonin can enhance sleep quality and quantity for medical residents working night shifts. Melatonin, a hormone that regulates sleep patterns, is available over the counter in the U.S. The trial compares melatonin to a placebo (a sugar pill with no active ingredients) to assess its effectiveness. Residents from anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics at the University of Virginia who do not currently use sleep aids or have certain health conditions might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding melatonin's effects in people, offering participants a chance to contribute to groundbreaking insights on sleep improvement.

Will I have to stop taking my current medications?

If you are currently using sleep aids, you will need to stop taking them to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial coordinators.

Is there any evidence suggesting that melatonin is likely to be safe for humans?

Research shows that melatonin is generally safe as a sleep aid. This hormone helps regulate sleep cycles and is available over the counter in the U.S. Studies have found that melatonin can help people adjust their sleep patterns when working night shifts.

Melatonin is usually well-tolerated, with only minor side effects reported. Common side effects include daytime sleepiness, headaches, and dizziness, occurring in less than 2% of users. Serious side effects are rare.

Both children and adults have used melatonin safely for sleep problems, though information on its long-term safety is limited. Overall, melatonin is considered a safe option for improving sleep, with most people experiencing only mild side effects, if any.12345

Why do researchers think this study treatment might be promising?

Melatonin is unique because it is a naturally occurring hormone that regulates sleep-wake cycles, unlike many standard treatments for sleep-wake disorders, which often involve prescription medications like benzodiazepines or non-benzodiazepine hypnotics. Researchers are excited about melatonin because it has the potential to improve sleep patterns with fewer side effects, as it mimics the body's own sleep-regulating mechanisms. Additionally, melatonin is available in over-the-counter forms, which could make it more accessible and convenient for patients if proven effective.

What evidence suggests that melatonin might be an effective treatment for sleep wake disorders?

This trial will compare the effects of melatonin with a placebo for sleep-wake disorders. Research has shown that melatonin can improve sleep for night shift workers, such as anesthesiology residents. As a hormone that regulates sleep and wake cycles, melatonin makes it easier to fall and stay asleep. Studies have found that melatonin can extend sleep duration and reset the body's internal clock. Although specific studies on anesthesiology residents are limited, melatonin has proven effective for similar sleep issues in other groups, suggesting it might help residents sleep better during night shifts.678910

Who Is on the Research Team?

LD

Lauren Dunn, MD PHD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am in my first to fifth year of post-graduate training.
Current enrollment in anesthesiology, general surgery, obstetrics and gynecology, general medicine, or pediatrics residency at the University of Virginia

Exclusion Criteria

History of a pacemaker or other medical device
Pregnant or breast-feeding females
I am currently using medication to help me sleep.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Monitoring

Participants undergo baseline sleep monitoring using EEG for 2-3 nights

1 week
No in-person visits, remote monitoring

Treatment

Participants receive either melatonin or placebo during night float shifts and are monitored using EEG

5-6 days
No in-person visits, remote monitoring

Recovery Monitoring

Participants are monitored for 3-4 nights following night float to assess recovery sleep patterns

1 week
No in-person visits, remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Melatonin
  • Placebo

Trial Overview

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).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Melatonin groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Melatonin is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Circadin for:
🇪🇺
Approved in European Union as Slenyto for:
🇺🇸
Approved in United States as Melatonin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Citations

Efficacy of melatonin with behavioural sleep-wake scheduling ...

Sleep disturbance, insomnia severity, and functional disability decreased, and a greater proportion of patients showed clinician-rated improvement following ...

Melatonin for sleep disorders in children with ... - PMC - NIH

The review concluded that melatonin was safe and effective in improving sleep for children with neurodevelopmental disorders. Another systematic ...

Slenyto - EMA

Slenyto is currently indicated for the treatment of insomnia in children and adolescents aged 2-18 with ASD and / or neurogenetic disorders with ...

Efficacy and Safety of Pediatric Prolonged-Release ...

The study met the primary endpoint: after 13 weeks of double-blind treatment, participants slept on average 57.5 minutes longer at night with PedPRM compared to ...

Research ReviewTM - STUDY REVIEW

The abnormal secretion and circadian rhythmicity of melatonin may be the explanation for the abnormal sleep–wake cycles reported in individuals with ASD.9 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31722088/

Adverse Events Associated with Melatonin for the ...

The most frequently reported AEs were daytime sleepiness (1.66%), headache (0.74%), other sleep-related AEs (0.74%), dizziness (0.74%) and hypothermia (0.62%).

Safety issues regarding melatonin use in child and ...

Abstract. Several studies have reported that melatonin may be effective in treating sleep problems in children and adolescents.

Assessment report - Slenyto - EMA

Lower melatonin concentrations have been found in blood and urine samples from children with autism which might explain the abnormal development of sleep/wake ...

Pediatric Melatonin Ingestions — United States, 2012–2021

Five children required mechanical ventilation, and two died. Consumers and health care professionals should be encouraged to report any melatonin product- ...

Attachment: Product Information for Melatonin

Therefore the medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. Autoimmune diseases.