The Role of the Circadian System in Neurological Sleep-wake Disorders (PNP)
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|ClinicalTrials.gov Identifier: NCT03356938|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy 1 Idiopathic Hypersomnia||Behavioral: Sleep restriction Behavioral: Sleep deprivation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official 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|
|Estimated Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
|No Intervention: Baseline recording|
|Experimental: Sleep restriction||
Behavioral: Sleep restriction
Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination
|Experimental: Sleep deprivation||
Behavioral: Sleep deprivation
Sleep deprivation during first night of sleep laboratory examination
- 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.
- 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.
- Performance in neurobehavioral tests [ Time Frame: One hour before each nap, up to 45mins. ]Outcome for vigilance and cognition of the subjects.
- EEG event related potentials (ERPs) [ Time Frame: One hour before each nap, up to 45minutes. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356938
|Contact: Esther Werth, PhD||0041 44 255 55 firstname.lastname@example.org|
|Contact: Franziska Ryser, MSc.||0041 44 255 10 email@example.com|
|University Hospital Zurich||Recruiting|
|Zürich, Switzerland, 8091|
|Contact: Esther Werth, PhD +41-(0)44-255-5535 firstname.lastname@example.org|
|Contact: Franziska Ryser, MSc. +41-(0)44-255-1043 email@example.com|
|Principal Investigator:||Esther Werth, PhD||University of Zurich|