Local Sleep in Idiopathic Hypersomnia (SL-HIP)

Sleeping With Open Eyes: Local Sleep in Idiopathic Hypersomnia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Hypersomnia
• Intervention / Treatment: Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Arnulf, MD, PhD; Phone Number: 01 42 16 77 04; Email: Isabelle.arnulf@aphp.fr

Study Locations

• France
  • Paris, France
    • Pitié Salpêtrière
    • Contact: Isabelle Arnulf, MD, PhD; Phone Number: 01 42 16 77 04; Email: Isabelle.arnulf@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Idiopathic Hypersomnia	Other: EEG (64 electrodes); EEG recording while awake, at rest then during an attentional cognitive test; Other: 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); Other: Pupillometry and eye tracking; Study of pupil size and gaze path during the cognitive test (correlated with alertness); Other: Thoracoabdominal belts; Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Active Comparator: Narcolepsy type 1	Other: EEG (64 electrodes); EEG recording while awake, at rest then during an attentional cognitive test; Other: 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); Other: Pupillometry and eye tracking; Study of pupil size and gaze path during the cognitive test (correlated with alertness); Other: Thoracoabdominal belts; Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
Active Comparator: Healthy subject	Other: EEG (64 electrodes); EEG recording while awake, at rest then during an attentional cognitive test; Other: 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); Other: Pupillometry and eye tracking; Study of pupil size and gaze path during the cognitive test (correlated with alertness); Other: Thoracoabdominal belts; Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Isabelle Arnulf, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Idiopathic Hypersomnia; Narcolepsia type 1
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Idiopathic Hypersomnia
• Other Study ID Numbers: APHP230749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be confidential until their publication in a peer reviewed journal. Sharing will be feasible after, in case of reasonable request to the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No