The Role of the Circadian System in Neurological Sleep-wake Disorders (PNP)

Esther Werth

Status

Completed

Conditions

Narcolepsy 1

Idiopathic Hypersomnia

Treatments

Behavioral: Sleep restriction

Behavioral: Sleep deprivation

Study type

Interventional

Funder types

Other

Identifiers

NCT03356938

CHPNP2016

Details and patient eligibility

About

The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed.

Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm.

This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.

Enrollment

36 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and Female participants 18 years to 35 years of age
Written informed consent by the participant after information about the research project
Healthy controls: 7-8 hours of sleep per night
Healthy controls: sleep satiation before start of the study
Narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased REM (MSLT), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available)
Idiopathic hypersomnia: diagnosis of idiopathic hypersomnia, drug free during study, proven excessive daytime sleepiness without increased REM (MSLT), increased sleep need (>10h/day) on work-free days shown by 2-week actigraphy

Exclusion criteria

signs of neurological, psychiatric, or other sleep-wake disorders
signs of sleep deprivation
shift work and time zone change of more than one hour within one month prior the study start
extreme morning and evening types
underweight
obstructive gastro-intestinal disease or history of gastrointestinal surgery
an implanted medical device or a scheduled MRI scan during the experimental period