Idiopathic Hypersomnia Clinical Trial
— SL-HIPOfficial title:
Sleeping With Open Eyes: Local Sleep in Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare and poorly studied disease characterized by excessive daytime sleepiness different from that of narcolepsy (sleep drunkness non-recuperative naps and nocturnal blackout). Local sleep is a recent concept, proposing a local regulation of the sleep-wake state, characterized by slow waves (SW) restricted to certain regions of a globally awake brain. The investigators are going to investigate whether local sleep could explain the sleepiness of these patients better than the global occurrence of sleep which are not very frequent during daytime tests in IH. The investigators propose to look for local sleep through the detection of local slow waves in the EEG of resting wakefulness and during an attentional task in people with IH compared to people with NT1 (sleepy, but with a different type of sleepiness from IH, more abrupt and including REM sleep) and non sleepy people.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Inclusion Criteria : - Healthy subjects and people with IH and NT1: ->18 years old, of both sexes, without legal protection. - Affiliated to the French social security system - Signature of free and informed consent - Fluency in spoken and written French - Specific to people with IH: -Diagnosis of IH according to the ICSD-3, already made in the sleep pathology department of the PitiƩ after a specialized medical interview and a standardized 48h assessment (Night 1+TILE+Night 2+two naps): Sleep time > 660 min or TILE latency <8 min, <2 SOREMPs. - Specific to people with NT1: - Diagnosis of narcolepsy type 1 according to the ICSD-3, already made in the sleep pathology department of the PitiƩ after a specialized medical interview and a standardized 48h workup (Night 1+TILE+Night 2+two naps) and sometimes a lumbar puncture: hypocretin <110 pmol/L in CSF or cataplexy and TILE latency <8 min, >1 SOREMP. Exclusion Criteria: - Shift or night work - Sleep debt on the day of the recording (questioning and sleep diary one week before the recording) - Other sleep pathology causing daytime sleepiness (sleep apnea, insomnia, parasomnia for example) - Cerebral neurological pathology - Depressive episode - Any psychotropic treatment modifying the EEG structure - Failure to wean from arousing treatment on the day of the test. - Inability to travel by transport or to be transported by a relative on the day of the recording. |
Country | Name | City | State |
---|---|---|---|
France | Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | local sleep topography | Density and topography of local sleep through the detection of local slow waves (SW) during resting wakefulness and during a daytime attentional test in IH, narcolepsy and healthy subjects | At enrollment visit | |
Secondary | Daytime dynamics of local sleep | Density and topography of local sleep through the detection of local slow waves at two times of the day. | At enrollment visit | |
Secondary | behavioral implications of local sleep | Correlation of slow wave characteristics to mental experience and performance (reaction time, omission, impulsivity) during the sustained attention task. | At enrollment visit | |
Secondary | correlation between local sleep and behavioral marker of alertness | Correlation of pupillometric and eye tracking measurements, respiratory and heart rate parameters (assessments correlated to the state of alertness) to the different measured parameters | At enrollment visit |
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