nravelling the sleepy brain: A neuroimaging study in central hypersomnolence disorders
- Conditions
- central hypersomnolence disordersnarcolepsy10040998
- Registration Number
- NL-OMON49234
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Patients:
- Definite narcolepsy type 1, narcolepsy type 2 or 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
- Capacity to provide informed consent
Healthy controls:
- Age between 18 and 65 years old
- Normal or corrected-to-normal vision
- Capacity to provide informed consent
The following exclusion criteria will apply:
- Systemic or neurological diseases (e.g., infections, inflammatory disorders,
dementia, epilepsy);
- Presence of another sleep-related disorder:
For patients:
Previous REM sleep behaviour disorder, insomnia, obstructive sleep apnoea, REM
sleep behaviour disorder or Restless legs syndrome diagnosis according to the
medical records
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
- 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 trauma capitis, encephalopathy, former intracranial surgery,
alcoholism or substance abuse
- Contraindications for MRI exam (e.g., claustrophobia, metallic implants)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>We will aim at assessing non-invasive MRI-related neural biomarkers in<br /><br>narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia by comparing<br /><br>them with acutely sleep-deprived controls and healthy controls. To create a<br /><br>reliable and elaborate combination of possible markers, the following<br /><br>neuroimaging will be used:<br /><br><br /><br>- Brain responses across the sleep-wake cycle using simultaneous EEG-fMRI<br /><br>- Brain responses during wakefulness using fMRI, especially in correlation with<br /><br>behavioral results in attentional and rewarded-associative memory tasks<br /><br>- Regional brain volumes and cortical thickness using MRI morphometry<br /><br>- White matter connectivity using DTI<br /><br>- Brain connectivity using structural covariance and resting-state fMRI<br /><br>functional connectivity<br /><br>- Regional GABA levels in the medial prefrontal cortex and posterior cingulate<br /><br>using MRS</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary analyses will include:<br /><br>- Correlation between neuroimaging activation maps and behavioral performance<br /><br>on the cognitive tasks.<br /><br>- Relationship between neuroimaging activation maps and clinical patient<br /><br>profiles (e.g. disease duration, subjective sleepiness and depression and<br /><br>anxiety scores)<br /><br>- Effect of sleep inertia on performance on the rewarded-associative memory task<br /><br>- The difference in molecular composition of exhaled breath between NT1, NT2<br /><br>and IH and secondary in comparison to acutely sleep-deprived controls and HC<br /><br>- Effect of acute sleep deprivation on molecular exhaled breath composition in<br /><br>healthy controls<br /><br><br /><br>As an exploratory objective, patients with idiopathic hypersomnia will be<br /><br>subcategorized in short (< 11 hours) and long (> 11 hours) sleepers and their<br /><br>neuroimaging profiles as defined in the primary objectives will be compared. </p><br>