Clinical Trials Directory

Trials / Completed

CompletedNCT03356938

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Esther Werth · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSleep restrictionRestricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination
BEHAVIORALSleep deprivationSleep deprivation during first night of sleep laboratory examination

Timeline

Start date
2017-11-28
Primary completion
2019-05-31
Completion
2020-05-31
First posted
2017-11-29
Last updated
2021-02-21

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03356938. Inclusion in this directory is not an endorsement.