NCT03356938: PNP

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

Completed NA Last updated 21 February 2021

What this trial tests

NA trial testing Sleep restriction in Narcolepsy 1 in 36 participants. Completed in 31 May 2020.

Timeline

28 November 2017

Primary endpoint
31 May 2019

31 May 2020

Quick facts

Lead sponsor	Esther Werth
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	36
Start date	28 November 2017
Primary completion	31 May 2019
Estimated completion	31 May 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Sleep restriction
• Sleep deprivation

Conditions studied

• Narcolepsy 1 — all drugs for Narcolepsy 1 →
• Idiopathic Hypersomnia — all drugs for Idiopathic Hypersomnia →

Sponsor

Esther Werth

Who can join

Adults 18 to 35, any sex, with Narcolepsy 1 or Idiopathic Hypersomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A novel method to increase specificity of sleep-wake classifiers based on wrist-worn actigraphy.
   Ryser F, Gassert R, Werth E, Lambercy O. · · 2023 · cited 2× · PMID 36938627 · DOI 10.1080/07420528.2023.2188096
2. Circadian Modulation of Sleep-Wake Behavior in Patients with Narcolepsy Type 1 and Idiopathic Hypersomnia.
   Ryser F, Windirsch AS, Baumann CR, Lambercy O, et al · · 2025 · PMID 41200473 · DOI 10.2147/nss.s520647