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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
Sponsor:
Information provided by (Responsible Party):
Esther Werth, University of Zurich

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE November 29, 2017
Last Update Posted Date November 30, 2017
Estimated Study Start Date  ICMJE November 30, 2017
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03356938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of the Circadian System in Neurological Sleep-wake Disorders
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Narcolepsy 1
  • Idiopathic Hypersomnia
Intervention  ICMJE
  • Behavioral: Sleep restriction
    Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination
  • Behavioral: Sleep deprivation
    Sleep deprivation during first night of sleep laboratory examination
Study Arms  ICMJE
  • No Intervention: Baseline recording
  • Experimental: Sleep restriction
    Intervention: Behavioral: Sleep restriction
  • Experimental: Sleep deprivation
    Intervention: Behavioral: Sleep deprivation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Esther Werth, PhD 0041 44 255 55 35 esther.werth@usz.ch
Contact: Franziska Ryser, MSc. 0041 44 255 10 43 franziska.ryser@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03356938
Other Study ID Numbers  ICMJE CHPNP2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Esther Werth, University of Zurich
Study Sponsor  ICMJE Esther Werth
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Esther Werth, PhD University of Zurich
PRS Account University of Zurich
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP