What keeps the brain alert? - A magnetic resonance study into the neural correlates of vigilance in narcolepsy patients

What keeps the brain alert? - A magnetic resonance study into the neural correlates of vigilance in narcolepsy patients - Vigilance and sleep resistance in the narcoleptic brain

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40453

Enrollment

Registered

2014-06-05

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

sleep disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For patients: - definite narcolepsy with cataplexy, diagnosed according to the International Classification for Sleep Disorders * Second Edition (ICSD 2) criteria; - confirmed hypocretin deficienct; - age between 18 and 65 years old; - treatment-naïve or stopping medication at least 14 days prior to the study start; - normal or corrected-to-normal vision; - informed consent.;For healthy controls: - age between 18 and 65 years old; - normal or corrected-to-normal vision; - matched to narcolepsy-cataplexy patients regarding age and gender; - informed consent.

Exclusion criteria

Exclusion criteria: - use of hypnotics or other sleep-wake active drugs; - younger than 18 or older than 65 years of age; - diagnosis of uncorrected visual problems (myopia/presbyopia, peripheral vision problems or legal blindness), or cylindrical corrections stronger than -1 dpt or any prismatic visual correction - current diagnosis of generalised anxiety disorder, depression or other psychiatric illness; - acute, unstable medical conditions or serious chronic diagnoses; - contra-indications for MR imaging studies.

Design outcomes

Primary

Measure	Time frame
All raw vigilance test data will be stored, but main outcome measures for the SART will be total errors of omission and total errors of commission. The comparison between patients and controls will be analysed using a multiple regression models including the number of trials. Spatiotemporal independent component analysis for the resting state activation using fMRI and GLM (general linear modelling: multivariate regression analyses) for the data-driven fMRI data using the software packages SPM5 (Wellcome Department of Cognitive Neurology, London, UK) and FSL (FMRIB laboratory, Oxford University, UK). Appropriate corrections for multiple comparisons will be performed (Bonferroni, family-wise error, cluster correction).	—

Measure

Time frame

All raw vigilance test data will be stored, but main outcome measures for the SART will be total errors of omission and total errors of commission. The comparison between patients and controls will be analysed using a multiple regression models including the number of trials. Spatiotemporal independent component analysis for the resting state activation using fMRI and GLM (general linear modelling: multivariate regression analyses) for the data-driven fMRI data using the software packages SPM5 (Wellcome Department of Cognitive Neurology, London, UK) and FSL (FMRIB laboratory, Oxford University, UK). Appropriate corrections for multiple comparisons will be performed (Bonferroni, family-wise error, cluster correction).

—

Secondary

Measure	Time frame
During the study day the subjects will undergo (verbal) IQ assessment using the National Adult Reading Test (NART) and assessment of daytime sleepiness by means of the Epworth Sleepiness Scale (ESS). These two measures will not be utilised to categorically subdivide study groups, but rather to base the later-stage final analysis on the performance on the ESS and the NART.	—

Countries

Netherlands

Outcome results