Clinical Trials Directory

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UnknownNCT06153615

Local Sleep in Idiopathic Hypersomnia

Sleeping With Open Eyes: Local Sleep in Idiopathic Hypersomnia

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

Local sleep is a recent concept, suggesting a local regulation of the sleep-wake state, characterized for example in wakefulness by slow waves restricted to certain regions of a globally awake brain, correlating with modifications of mental experience and behavior. Although the phenomenon of local sleep has been demonstrated following acute sleep deprivation, its importance in explaining attentional fluctuations during a normal day is only beginning to be investigated. Moreover, inter-individual variations remain unexplored. The investigators propose to study in EEG (64 electrodes) the occurrence of local sleep in different states of sleepiness, in particular in idiopathic hypersomnia (IH) in comparison to that of narcolepsy type 1 (NT1) and to non-drowsy individuals, both in the resting state and during a sustained attention test (SART). This study will provide a better understanding of intra- (over the course of a day) and inter-individual fluctuations in the local sleep phenomenon potentially involved in this disease and its impact on cognition. Anticipated number of participants: 60 including: * 20 people with idiopathic hypersomnia * 20 people with type 1 narcolepsy * 20 people with no previous history Practical procedure: Single visit: presence from 9:30 am to 3:30 pm * General questionnaire on sleep habits and symptoms. * Equipment: EEG 32 electrodes, EOG, ECG, eye tracker and thoracoabdominal belts. * Morning and afternoon recording: 10 minutes in resting state, 60 minutes of digital SART (go-no-go test in front of a screen, with intermittent evaluation of mental state), then 10 minutes of rest.

Conditions

Interventions

TypeNameDescription
OTHEREEG (64 electrodes)EEG recording while awake, at rest then during an attentional cognitive test
OTHERCognitive task (SART)Sustained attention go-no-go task (press a button each time a number is presented on a screen (1/second) except when the 3 appears) Assessment of mental status approximately every 45 seconds (task focus, mind wandering, mental blank, and sleepiness status)
OTHERPupillometry and eye trackingStudy of pupil size and gaze path during the cognitive test (correlated with alertness)
OTHERThoracoabdominal beltsAbdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)

Timeline

Start date
2023-12-01
Primary completion
2023-12-01
Completion
2024-05-01
First posted
2023-12-01
Last updated
2023-12-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06153615. Inclusion in this directory is not an endorsement.