Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-31
2024-05-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Idiopathic Hypersomnia
EEG (64 electrodes)
EEG recording while awake, at rest then during an attentional cognitive test
Cognitive 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)
Pupillometry and eye tracking
Study of pupil size and gaze path during the cognitive test (correlated with alertness)
Thoracoabdominal belts
Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Narcolepsy type 1
EEG (64 electrodes)
EEG recording while awake, at rest then during an attentional cognitive test
Cognitive 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)
Pupillometry and eye tracking
Study of pupil size and gaze path during the cognitive test (correlated with alertness)
Thoracoabdominal belts
Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Healthy subject
EEG (64 electrodes)
EEG recording while awake, at rest then during an attentional cognitive test
Cognitive 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)
Pupillometry and eye tracking
Study of pupil size and gaze path during the cognitive test (correlated with alertness)
Thoracoabdominal belts
Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Interventions
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EEG (64 electrodes)
EEG recording while awake, at rest then during an attentional cognitive test
Cognitive 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)
Pupillometry and eye tracking
Study of pupil size and gaze path during the cognitive test (correlated with alertness)
Thoracoabdominal belts
Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Eligibility Criteria
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Inclusion Criteria
-\>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 Pitié 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 Pitié 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
* 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.
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Isabelle Arnulf, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Pitié Salpêtrière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Isabelle Arnulf, MD, PhD
Role: primary
Other Identifiers
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APHP230749
Identifier Type: -
Identifier Source: org_study_id