BridgeMD
HyperChrono
EU CTIS ID: 2023-506663-33-00
What this study is testing
The main objective of this trial is to demonstrate, in adult patients affected with IH, the efficacy of 6 weeks of chronobiotherapy (combining evening fast release 2mg melatonin and morning bright light therapy), compared to placebo therapy (combining evening placebo drug and morning placebo light), on reducing IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patient
- Age ≥ 18 and ≤ 45 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 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 5 years
- Patient with stable medication during the 11 weeks of participation to the study (except for drugs excluding participation.
- Patient able to be compliant with chronobiotherapy during the required time and at the set schedule.
- For female patient: effective efficient contraception or sexual abstinence during the month preceding the inclusion and all along the study
You likely can't join if
- Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…)
- Patient in emergency situation
- Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder).
- Patient in life-threatening situation
- Patient sous sauvegarde de justice
- Patient under guardianship or limited guardianship
See the full eligibility criteria
- Male or female patient
- Age ≥ 18 and ≤ 45 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 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 5 years
- Patient with stable medication during the 11 weeks of participation to the study (except for drugs excluding participation.
- Patient able to be compliant with chronobiotherapy during the required time and at the set schedule.
- For female patient: effective efficient contraception or sexual abstinence 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
- Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…)
- Patient in emergency situation
- Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder).
- Patient in life-threatening situation
- Patient sous sauvegarde de justice
- Patient under guardianship or limited guardianship
- Known systemic or severe acute disease (auto-immune diseases…)
- Substance / alcohol /cigarette dependence
- Recent transmeridian travel (> 2 time zones) within the month before the start of the study
- Wake promoting-drugs (modafinil, pitolisant, methylphenidate, solriamfétol chlorhydrate)
- History of shift/night work reported within the 6 months preceding the study
- Photosensitive epilepsia or migraine
- 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, …)
- • Consumption of excessive amounts of caffeine, defined as greater than 600 mg of caffeine (coffee, tea, cola, energy drinks, or other caffeinated beverages per day ; 1 cup of coffee is approximately 120 mg)
- • Patient unwilling to refrain from driving and/or operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue due to the medication
- 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)
- 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
- Prior intolerance to cellulose or exogenous melatonin
- Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia)
- Drugs metabolized by CYP1A2 intake prohibited during the study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin…
- Pregnancy, breastfeeding.
- Sleep promoting drugs (benzodiazepines, z-drugs, sodium oxybate, antihistaminics…)
- Participation in another interventional clinical trial with an exclusion period
- Patient with difficulty to read or understand French, or inability to understand the delivered information
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.