Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153615
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-09-29
Brief Title:
Local Sleep in Idiopathic Hypersomnia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Sleeping With Open Eyes Local Sleep in Idiopathic Hypersomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SL-HIP
Brief 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
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 930 am to 330 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
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 930 am to 330 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None