Local Sleep in Idiopathic Hypersomnia

NCT06153615 | Unknown

• 1 other identifier: APHP230749
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Hypersomnia

Keywords

Idiopathic Hypersomnia; Narcolepsia type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Daytime dynamics of local sleep

  At enrollment visit

• behavioral implications of local sleep

  At enrollment visit

• correlation between local sleep and behavioral marker of alertness

  At enrollment visit

Study Arms (3)

Idiopathic Hypersomnia

EXPERIMENTAL

Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts

Narcolepsy type 1

ACTIVE COMPARATOR

Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts

Healthy subject

ACTIVE COMPARATOR

Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts

Interventions

EEG (64 electrodes) OTHER

EEG recording while awake, at rest then during an attentional cognitive test

Healthy subject; Idiopathic Hypersomnia; Narcolepsy type 1

Cognitive task (SART) OTHER

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)

Healthy subject; Idiopathic Hypersomnia; Narcolepsy type 1

Pupillometry and eye tracking OTHER

Study of pupil size and gaze path during the cognitive test (correlated with alertness)

Healthy subject; Idiopathic Hypersomnia; Narcolepsy type 1

Thoracoabdominal belts OTHER

Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)

Healthy subject; Idiopathic Hypersomnia; Narcolepsy type 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpêtrière

Paris, France

Location

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Isabelle Arnulf, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Arnulf, MD, PhD

CONTACT

01 42 16 77 04; isabelle.arnulf@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)