Study on Melatonin and Light Therapy for Adults with Idiopathic Hypersomnia

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What is this study about?

This clinical trial is focused on studying Idiopathic Hypersomnia, a condition characterized by excessive daytime sleepiness despite having a good night’s sleep. The treatment being tested involves a combination of evening doses of melatonin and morning light therapy. Melatonin is a natural hormone that helps regulate sleep-wake cycles, and in this study, it is given in a fast-release form as a capsule. The study also includes a comparison with a placebo, which is a substance with no active therapeutic effect.

The purpose of the study is to evaluate the effectiveness of this treatment in reducing symptoms of idiopathic hypersomnia. Participants will be randomly assigned to receive either the active treatment or the placebo for a period of six weeks. During this time, they will take a 2 mg dose of melatonin in the evening and undergo bright light therapy in the morning, or they will receive the placebo equivalents. The study aims to measure changes in symptoms using a specific scale designed for idiopathic hypersomnia.

Participants will be monitored throughout the study to assess any changes in their condition. The trial is designed to provide valuable information on whether this combination of melatonin and light therapy can help manage symptoms of idiopathic hypersomnia effectively. The study will last for a total of 45 days, with regular check-ins to track progress and ensure the safety and well-being of all participants.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, diagnosis of idiopathic hypersomnia, and other criteria.

Participants must have stable medication for at least one month prior to the study and throughout the 10-week participation period.

2 informed consent

Participants will be required to provide written informed consent, acknowledging understanding of the study’s objectives and potential risks.

Female participants must ensure effective contraception during the month preceding the study and throughout its duration.

3 randomization

Participants will be randomly assigned to one of two groups: the active treatment group or the placebo group.

The active treatment group will receive 2mg melatonin in the evening and bright light therapy in the morning.

4 treatment phase

The treatment phase lasts for 6 weeks. Participants in the active group will take 2mg melatonin orally each evening and undergo bright light therapy each morning.

Participants in the placebo group will receive a placebo drug and placebo light therapy.

5 symptom assessment

Throughout the study, symptoms will be monitored using the Idiopathic Hypersomnia Severity Scale (IHSS).

The primary goal is to measure the change in IHSS score before and after the 6-week treatment period.

6 study completion

At the end of the 6-week period, participants will undergo a final assessment to evaluate the effects of the treatment.

The study aims to determine the efficacy of the treatment in reducing symptoms of idiopathic hypersomnia.

Who Can Join the Study?

Must be a male or female patient.
Must be between 18 and 40 years old at the time of signing the consent form.
Must have been diagnosed with Idiopathic Hypersomnia at a specialized center, with symptoms lasting more than 3 months and a total sleep time of at least 11 hours, confirmed by a sleep study done in the last 12 months.
Must have stable medication for the month before joining the study and during the 10 weeks of the study (except for medications that would exclude participation).
Must be able to follow the chronobiotherapy treatment schedule. (Chronobiotherapy involves treatments that are timed to the body’s natural rhythms, like taking medication at specific times.)
If female, must use effective contraception during the month before joining and throughout the study.
Must have given written consent and be able to understand the study’s goals and risks.
Must be affiliated with a social security insurance.

Who Cannot Join the Study?

Patients who are not diagnosed with Idiopathic Hypersomnia cannot participate. Idiopathic Hypersomnia is a condition where a person feels excessively sleepy during the day, even after a good night’s sleep.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Assistance Publique Hopitaux De Paris	Paris	France
Assistance Publique Hopitaux De Paris	Paris	France
Pellegrin Hospital	Bordeaux	France
Hopital Saint Eloi	Montpellier	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2023

Trial locations

Investigated drugs:

Melatonin

Melatonin is a hormone that your body naturally produces, and it helps regulate your sleep-wake cycle. In this trial, melatonin is used in the evening to help manage sleep patterns for people with idiopathic hypersomnia, a condition where you feel excessively sleepy during the day. The goal is to see if taking melatonin can help reduce the symptoms of this condition.

Bright Light Therapy is a treatment that involves exposure to a bright light, usually in the morning. This therapy is used to help adjust your internal body clock, which can improve your alertness and energy levels during the day. In this trial, bright light therapy is combined with melatonin to see if it can further help reduce the symptoms of idiopathic hypersomnia by improving your sleep-wake cycle.

Idiopathic Hypersomnia – Idiopathic Hypersomnia is a sleep disorder characterized by excessive daytime sleepiness despite having a normal or extended amount of nighttime sleep. Individuals with this condition often experience difficulty waking up after long sleep periods and may feel unrefreshed upon waking. The disorder can lead to prolonged sleep episodes during the day and a persistent feeling of grogginess or sleep inertia. Unlike narcolepsy, idiopathic hypersomnia does not typically involve sudden muscle weakness or sleep attacks. The exact cause of idiopathic hypersomnia is unknown, and it is considered a rare condition. Symptoms can vary in intensity and may fluctuate over time.

Trial ID:

2023-506663-33-00

Protocol code:

8443

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Melatonin and Light Therapy for Adults with Idiopathic Hypersomnia

What is this study about?

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