BridgeMD
New treatment option for Idiopathic Hypersomnia
Official title a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial
ClinicalTrials.gov ID: NCT06252571
What this study is testing
What is - Melatonin - Active light ttherapy?
- Melatonin - Active light ttherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic hypersomnia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Idiopathic hypersomnia (IH) is a chronic disabling disorder characterized by excessive daytime sleepiness (EDS), prolonged nighttime sleep and sleep inertia. IH is a rare disorder, estimated around 0.05%, yet its true prevalence remains unknown.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Male or female patient
- Age ≥ 18 and ≤ 40 years at signature of informed consent form
- Diagnosed with Idiopathic hypersomnia in a reference/competence center of hypersomnia rare disease network according to ICSD-3 criteria...
- Patient with stable medication in the month preceding inclusion and throughout the 10 weeks of participation to the study (except for drugs excluding...
- Patient able to be compliant with therapy during the required time and at the set schedule.
You likely can't join if
- Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder)
- Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance...
- Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia)
- Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness:
- Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar...
- Known systemic or severe acute disease (auto-immune diseases…)
See the full eligibility criteria
- Male or female patient
- Age ≥ 18 and ≤ 40 years at signature of informed consent form
- Diagnosed with Idiopathic hypersomnia in a reference/competence center of hypersomnia rare disease network according to ICSD-3 criteria (International classification of sleep disorders) with symptoms lasting since \>3...
- Patient with stable medication in the month preceding inclusion and throughout the 10 weeks of participation to the study (except for drugs excluding participation. See list below).
- Patient able to be compliant with therapy during the required time and at the set schedule.
- For female patient: effective efficient contraception during the month preceding the inclusion and all along the study
- Patient who have given written informed consent and are able to understand the objectives and risks associated to the research.
- Patient affiliated to a social security insurance
- Criteria related to the underlying disorder (other forms of hypersomnia or sleep disorder)
- Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…)
- Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia)
- Criteria related to pathologies associated with particular risks or consumption of substances that may affect sleep or alertness:
- Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder).
- Known systemic or severe acute disease (auto-immune diseases…)
- Substance / alcohol /cigarette dependence
- Consumption of excessive amounts of caffeine, defined as greater than 600 mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day (1 cup of coffee is approximately 120 mg)
- Criteria related to circadian rhythms disturbances
- Recent transmeridian travel (\> 2 time zones) within the month before the start of the study
- History of shift/night work reported within the 6 months preceding the study
- Irregular sleep habits (more than 2 hours of delay or advance in bedtime ≥ 3 nights over a week)
- Circadian sleep-wake rhythm disorders according to ICSD-3 criteria (advanced or delayed sleep phase syndrome, …)
- criteria related to medications (within 1 month prior to study)
- Sleep promoting drugs (benzodiazepines, z-drugs, sodium oxybate, antihistaminics…)
- Wake promoting-drugs (modafinil, pitolisant, methylphenidate, solriamfétol chlorhydrate)
- Psychotropics and drugs inducing level 3 sleepiness according to the ANSM (French National Agency for Medicines and Health Products Safety) gradation.
- beta-blockers
- regular anti-inflammatory drug intake
- Exogenous melatonin and/or serotonin and or tryptohane (as a drug or a dietary supplement)
- Criteria related to relative contra-indications to light therapy
- Medical history of ophthalmologic diseases causing visual impairment: retinopathy, age-related macular degeneration, macular hole, epiretinal membrane; cataract; optic neuropathy.
- On-going medication with a photosensibilizing drug
- Photosensitive epilepsia or migraine
- Criteria relative to exogenous melatonin administration
- Prior intolerance to cellulose or exogenous melatonin
- Drugs metabolized by CYP1A2 intake within 1 month prior to study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin…
- Criteria relative to relative contraindications of e-celsius capsules
- Patient weighting less than 40 kg
- Medical history of motility disorders of the gastrointestinal tract and intestinal disorders that can lead to obstruction of the digestive tract, including diverticula, Crohn disease, surgical procedures in the...
- Known swallowing disorders
- In presence of a pacemaker or electro-medical implant.
- Patient who has to undergo strong electromagnetic field during the period of use of the system (MRI)
- Criteria relative to regulation:
- Pregnancy, breastfeeding.
- Participation in another treatment clinical trial with an exclusion period
- Patient with difficulty to read or understand French, or inability to understand the delivered information
- Patient in emergency situation
- Patient in life-threatening situation
- Patient under justice safeguard
- Patient under guardianship or limited guardianship
- Patient unwilling to refrain from driving and/or operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue due to the medication
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.