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NCT Number: NCT03356938

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

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.

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Key information

Conditions

Narcolepsy 1 Disorders of Excessive Somnolence Dyssomnias Idiopathic Hypersomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Restriction

Behavioral

Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination

Sleep deprivation

Behavioral

Sleep deprivation during first night of sleep laboratory examination

Primary outcomes

  1. Endogenous melatonin

    Time frame: Half an hour before and half an hour after a nap during PNP protocol, up to 2 minutes.

    Dim light melatonin onset (DLMO) will show whether there is a phase difference between patient groups and between patients and controls. The amplitude of the melatonin profile will show whether there is a dampening of the circadian rhythm or not.

  2. EEG slow-wave activity (SWA)

    Time frame: Over nap times, up to 80 minutes.

    SWA is a marker of homeostatic sleep pressure and will show whether patients with narcolepsy or idiopathic hypersomnia live under different sleep pressure than controls.

Secondary outcomes

  1. Performance in neurobehavioral tests

    Time frame: One hour before each nap, up to 45mins.

    Outcome for vigilance and cognition of the subjects.

  2. EEG event related potentials (ERPs)

    Time frame: One hour before each nap, up to 45minutes.

Sponsors and collaborators

Lead sponsor

Esther Werth

Other

Registry information

Official study title

The Role of the Circadian System in Neurological Sleep-wake Disorders: Assessment of Circadian and Homeostatic Sleep-wake Regulation and Vigilance With a Poly-nap Protocol

Acronym: PNP

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 29, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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