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

Unravelling the sleepy brain: A neuroimaging study in central hypersomnolence disorders - Neuroimaging in central hypersomnolence disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49234
Enrollment
60
Registered
2019-07-23
Start date
2019-08-19
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central hypersomnolence disorders narcolepsy

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 ( 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)

Design outcomes

Primary

MeasureTime frame
We will aim at assessing non-invasive MRI-related neural biomarkers in narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia by comparing them with acutely sleep-deprived controls and healthy controls. To create a reliable and elaborate combination of possible markers, the following neuroimaging will be used: - Brain responses across the sleep-wake cycle using simultaneous EEG-fMRI - Brain responses during wakefulness using fMRI, especially in correlation with behavioral results in attentional and rewarded-associative memory tasks - Regional brain volumes and cortical thickness using MRI morphometry - White matter connectivity using DTI - Brain connectivity using structural covariance and resting-state fMRI functional connectivity - Regional GABA levels in the medial prefrontal cortex and posterior cingulate using MRS

Secondary

MeasureTime frame
The secondary analyses will include: - Correlation between neuroimaging activation maps and behavioral performance on the cognitive tasks. - Relationship between neuroimaging activation maps and clinical patient profiles (e.g. disease duration, subjective sleepiness and depression and anxiety scores) - Effect of sleep inertia on performance on the rewarded-associative memory task - The difference in molecular composition of exhaled breath between NT1, NT2 and IH and secondary in comparison to acutely sleep-deprived controls and HC - Effect of acute sleep deprivation on molecular exhaled breath composition in healthy controls As an exploratory objective, patients with idiopathic hypersomnia will be subcategorized in short ( 11 hours) sleepers and their neuroimaging profiles as defined in the primary objectives will be compared.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)