MedPath

nravelling the sleepy brain: A neuroimaging study in central hypersomnolence disorders

Recruiting
Conditions
arcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia
Registration Number
NL-OMON24942
Lead Sponsor
CIHR
Brief Summary

A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

Patients:
• Definite narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia, diagnosed according to the International Classification for Sleep Disorders – Third Edition (ICSD-3) criteria;
• Age between 18 and 65 years old;
• Normal or corrected-to-normal vision;
• Informed consent.

Healthy controls:
• Age between 18 and 65 years old;
• Normal or corrected-to-normal vision;
• Informed consent.

Exclusion Criteria

• Systemic or neurological diseases (e.g., infections, inflammatory disorders, dementia, epilepsy);
• Having worked on night shifts during the last month;
• < 18 or > 65 years of age;
• Major psychiatric disorder (e.g., major depression, psychotic or bipolar disorder);
• History of head injury, encephalopathy, former intracranial surgery, alcoholism or substance abuse;
• Contraindications for MRI exam (e.g., claustrophobia, metallic implants).

For patients:
• Previous REM sleep behaviour disorder, insomnia, obstructive sleep apnoea or restless legs syndrome diagnosis according to the medical records;
• REM sleep behaviour disorder or restless legs syndrome symptoms at least 1x/month as screened with the Single-Question Screening for REM Sleep Behaviour Disorder and Restless Legs Syndrome Screening Questionnaire.

For healthy controls:
• REM sleep behaviour disorder as screened by the Single-Question Screening for REM Sleep Behaviour Disorder;
• Restless legs syndrome as screened by the Restless Legs Syndrome Screening Questionnaire (score > 6);
• High-risk for obstructive sleep apnoea according to the Stop-Bang questionnaire (score > 4);
• Insomnia disorder by the Insomnia Severity Index (score > 14);
• Circadian rhythm disorder;
• Short sleepers (< 6 hours on average) or irregular sleep schedules.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
eural correlates on regional brain volumes (cortical thickness, surface area, subcortical volumes), white matter integrity (fractional anisotropy and mean, radial and axial diffusivity) and BOLD response in patients with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia versus healthy well-rested controls and acutely sleep-deprived controls during resting-state, sleep and while performing a vigilance task and a rewarded-associative memory task.
Secondary Outcome Measures
NameTimeMethod
eurocognitive performance profiles during the SART (response time, number of omission and commission errors, total errors), reward-associative memory task (response time, number of correct and incorrect responses) and multidimensional attention task (response time, number of correct and incorrect responses), questionnaire results (PSQI, ESS, SIQ, HADS and KSS scores) and sleep habits in the week prior to MRI acquisition (duration).
© Copyright 2025. All Rights Reserved by MedPath