Local Sleep in Idiopathic Hypersomnia

Idiopathic Hypersomnia Clinical Trial

— SL-HIP  

Official title:

Sleeping With Open Eyes: Local Sleep in Idiopathic Hypersomnia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153615
• Other study ID #: APHP230749
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Isabelle Arnulf, MD, PhD
• Phone: 01 42 16 77 04
• Email: isabelle.arnulf[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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 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:

• 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.

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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