Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are aged between 18 and 40 years old at the time of signing the consent form
• People who have been diagnosed with Idiopathic Hypersomnia (a condition causing excessive sleepiness) at a specialist sleep disorder centre, following recognised international diagnostic guidelines, with symptoms lasting more than 3 months and a total daily sleep time of 11 hours or more, confirmed by an overnight sleep study done within the last 12 months
• People whose medications have remained unchanged in the month before joining and throughout the 10-week study period (except for medications that exclude participation — see exclusion list)
• People who are able to follow the treatment schedule consistently for the required period
• Women of childbearing potential who have been using effective contraception for at least one month before joining and throughout the study
• People who have given written consent and understand the goals and risks of the research
• People who are covered by a social security insurance scheme

Who may not be able to join:

• People with another form of hypersomnia or sleep disorder, such as narcolepsy, Kleine-Levin syndrome, sleep apnoea, restless legs syndrome, insomnia, or hypersomnia caused by medication or substance use
• People with significant mental health conditions, including a current severe depressive episode, risk of suicide, schizophrenia, or bipolar disorder
• People with a known serious ongoing illness, such as an autoimmune disease
• People with dependence on substances, alcohol, or cigarettes
• People who consume more than 600 mg of caffeine per day (roughly equivalent to five cups of coffee)
• People who have travelled across more than two time zones in the month before the study starts
• People who have done shift work or night work in the six months before the study
• People with irregular sleep patterns, such as going to bed more than two hours earlier or later than usual on three or more nights per week
• People with a diagnosed circadian rhythm sleep disorder (such as delayed or advanced sleep phase syndrome)
• People who have taken sleep-promoting medications (such as benzodiazepines or sodium oxybate) within the month before the study
• People who have taken wake-promoting medications (such as modafinil or methylphenidate) within the month before the study
• People who have taken certain psychiatric medications or medications classified as causing a high level of drowsiness within the month before the study
• People who have taken beta-blockers, regular anti-inflammatory medications, melatonin, serotonin, or tryptophan (whether as a medication or dietary supplement) within the month before the study
• People with a history of certain eye conditions that affect vision, such as retinal disease, macular degeneration, cataracts, or optic nerve damage
• People currently taking medication that increases sensitivity to light
• People with light-sensitive epilepsy or migraines triggered by light
• People with a known intolerance to cellulose or melatonin
• People taking certain medications that interact with the liver enzyme CYP1A2 (such as fluvoxamine, carbamazepine, or rifampicin) within the month before the study (confirm with trial site)
• People who weigh less than 40 kg
• People with a history of gastrointestinal conditions or bowel disorders that could cause blockages in the digestive tract, such as Crohn's disease or diverticular disease, or who have had gastrointestinal surgery
• People with known difficulty swallowing
• People who have a pacemaker or other electronic medical implant
• People who would need an MRI scan during the study period
• People who are pregnant or breastfeeding
• People currently participating in another clinical trial with an exclusion period that overlaps
• People who have difficulty reading or understanding French, or who cannot understand the information provided
• People in an emergency or life-threatening situation
• People under legal protection orders, guardianship, or limited guardianship
• People who are unwilling to avoid driving or operating dangerous machinery during periods of increased sleepiness or fatigue related to the study medication

Important: Always verify eligibility with the trial site directly before applying.