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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

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.


Condition or disease Intervention/treatment Phase
Narcolepsy 1 Idiopathic Hypersomnia Behavioral: Sleep restriction Behavioral: Sleep deprivation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356938


Contacts
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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

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Esther Werth, PhD    +41-(0)44-255-5535    esther.werth@usz.ch   
Contact: Franziska Ryser, MSc.    +41-(0)44-255-1043    franziska.ryser@usz.ch   
Sponsors and Collaborators
Esther Werth
Investigators
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Principal Investigator: Esther Werth, PhD University of Zurich

Publications:
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Responsible Party: Esther Werth, Head of Sleep Laboratory, University of Zurich
ClinicalTrials.gov Identifier: NCT03356938     History of Changes
Other Study ID Numbers: CHPNP2016
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Wake Disorders
Parasomnias
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms