Idiopathic HypersomniaSL-HIPNCT06153615
Local Sleep in Idiopathic Hypersomnia
A study testing EEG (64 electrodes), Cognitive task (SART) and Pupillometry and eye tracking in people with Idiopathic Hypersomnia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- EEG (64 electrodes), Cognitive task (SART) and Pupillometry and eye tracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2024to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- 23 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
- Idiopathic Hypersomnia
- Being tested
- EEG (64 electrodes), Cognitive task (SART), Pupillometry and eye tracking, Thoracoabdominal belts
- Keywords
- Idiopathic Hypersomnia, Narcolepsia type 1
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG (64 electrodes)Other
EEG recording while awake, at rest then during an attentional cognitive test
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)
Pupillometry and eye trackingOther
Study of pupil size and gaze path during the cognitive test (correlated with alertness)
Thoracoabdominal beltsOther
Abdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness)
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Hypersomnia | Experimental | Not described Receives: Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts |
| Narcolepsy type 1 | Active comparator | Not described Receives: Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts |
| Healthy subject | Active comparator | Not described Receives: Other: EEG (64 electrodes); Other: Cognitive task (SART); Other: Pupillometry and eye tracking; Other: Thoracoabdominal belts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment visit
Secondary outcomes (3)
Daytime dynamics of local sleep
Density and topography of local sleep through the detection of local slow waves at two times of the day.
Measured: 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.
Measured: 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
Measured: At enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start2 Feb 2024
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Arnulf, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153615
- Sponsor's protocol ID
- APHP230749
- Other IDs
- IDRCB 2023-A01145-40
- Acronym
- SL-HIP
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeping With Open Eyes: Local Sleep in Idiopathic Hypersomnia
- ClinicalTrials.gov ID
- NCT06153615
- Acronym / sponsor ID
- SL-HIP / APHP230749
- Conditions
- Idiopathic Hypersomnia
- Keywords
- Idiopathic Hypersomnia, Narcolepsia type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 23 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy subjects and people with IH and NT1:
- ->18 years old, of both sexes, without legal protection.
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG (64 electrodes)EEG recording while awake, at rest then during an attentional cognitive test | Other | Healthy subject, Idiopathic Hypersomnia, Narcolepsy type 1 |
| 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 | Healthy subject, Idiopathic Hypersomnia, Narcolepsy type 1 |
| Pupillometry and eye trackingStudy of pupil size and gaze path during the cognitive test (correlated with alertness) | Other | Healthy subject, Idiopathic Hypersomnia, Narcolepsy type 1 |
| Thoracoabdominal beltsAbdominal and thoracic belts (used in all nocturnal polysomnographic recordings) for respiratory movement studies (correlated with sleepiness) | Other | Healthy subject, Idiopathic Hypersomnia, Narcolepsy type 1 |
Primary outcome
local sleep topography
Time frame: At enrollment visit
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
3 secondary outcomes
Daytime dynamics of local sleep
Time frame: At enrollment visit
behavioral implications of local sleep
Time frame: At enrollment visit
correlation between local sleep and behavioral marker of alertness
Time frame: At enrollment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Arnulf, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG (64 electrodes), Cognitive task (SART) and Pupillometry and eye tracking in people with Idiopathic Hypersomnia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local sleep topography (time frame: At enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.