CTIS2023-506663-33-00进行中（未招募）1 期
A CHRONOBIOLOGICAL TREATMENT combining evening melatonin and morning light therapy IN IDIOPATHIC HYPERSOMNIA: a prospective, double bind, randomized, placebo-controlled -trial - 8443
es Hopitaux Universitaires De Strasbourg0 个研究点目标入组 72 人开始时间: 2023年8月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •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 months and a total sleep time =11hours objectified with a 24h continuous polysomnography realized during the last 12 months, Patient with stable medication in the month preceding inclusion and throughout the 10 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 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
排除标准
- •Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…), Photosensitive epilepsia or migraine, 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 within 1 month prior to study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin…, 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 gastrointestinal tract, 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), 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, 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, 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
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