What side effects are associated with this type of intervention?

Melatonin, commonly used to treat Circadian Rhythm Disorders, is generally well tolerated with few serious adverse effects reported. Common side effects include headaches, somnolence, hypotension, hypertension, and gastrointestinal upset. Higher doses may exacerbate conditions like alopecia areata. Long-term safety data are limited, but short-term use of ≤10 mg/day appears safe in healthy adults. Caution is advised in children, adolescents, and women of reproductive age due to sparse reports of adverse effects. Other treatments like tasimelteon may cause headaches, elevated liver function tests, and abnormal dreams.

What prior FDA approvals exist?

Tasimelteon and ramelteon are two FDA-approved melatonin receptor agonists used for the treatment of circadian rhythm disorders. Tasimelteon is specifically approved for Non-24-Hour Sleep-Wake Disorder (N24SWD) in blind individuals, while ramelteon is approved for insomnia characterized by difficulty with sleep onset. Both drugs work by targeting melatonin receptors to help regulate the sleep-wake cycle.

What other types of research exist?

Promising novel alternatives to melatonin for circadian rhythm disorder patients include: 1) Morning light therapy using broad-spectrum white light boxes, which can help shift circadian rhythms earlier. 2) Strategic avoidance of evening light, such as using amber or blue-blocker glasses to reduce exposure to specific wavelengths of light before bedtime. 3) Light flashes during sleep and wearable light devices, which are new developments in light treatment. These alternatives have shown potential in clinical studies and are considered low-risk interventions.

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Hormone Therapy

Melatonin for Sleep Wake Disorders

Q: What is the mechanism of action of this treatment?

Common treatments for Circadian Rhythm Disorder include melatonin and light therapy. Melatonin works by signaling to the body that it is time to sleep, helping to realign the circadian rhythm and increase sleep duration. Light therapy involves exposure to bright light at specific times to shift the circadian rhythm earlier or later, depending on the timing of the light exposure. These treatments are essential for correcting the misalignment of the internal body clock with the external environment, thereby improving sleep quality and overall functioning in patients with Circadian Rhythm Disorder.

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

Must not have

Current use of sleep aids

History of transplant on immunosuppression therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Summary

This trial tests if melatonin can help medical residents who work night shifts sleep better by resetting their internal clocks. Melatonin has been studied for its ability to reset circadian rhythms and improve sleep in night shift workers.

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.

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).

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using medication to help me sleep.

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I have had a transplant and am on medication to suppress my immune system.

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I have been diagnosed with a sleep disorder.

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I have a bleeding disorder.

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I have been diagnosed with depression.

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I have high blood pressure.

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I have a seizure disorder.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total Sleep Time (TST)

Secondary study objectives

Deep Sleep

Latency to Persistent Sleep (LPS)

Light Sleep

+3 more

Other study objectives

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Circadian Rhythm Disorder include melatonin and light therapy. Melatonin works by signaling to the body that it is time to sleep, helping to realign the circadian rhythm and increase sleep duration. Light therapy involves exposure to bright light at specific times to shift the circadian rhythm earlier or later, depending on the timing of the light exposure. These treatments are essential for correcting the misalignment of the internal body clock with the external environment, thereby improving sleep quality and overall functioning in patients with Circadian Rhythm Disorder.

The circadian basis of winter depression.