Exploring the Recovery Function of Sleep in Neurodegeneration

Not Applicable

Recruiting

• Conditions: Neurodegenerative Diseases
• Interventions: Behavioral: Auditory stimulation

• Registration Number: NCT05402488
• Lead Sponsor: University of Zurich

Brief Summary

The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.

Detailed Description

First, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. Healthy subjects will be assessed for procedure validation and reference purposes. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.

Study Timeline

• Study First Submitted: 2021-12-21
• Study Start: 2022-03-14
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria
• Age above 18 years
• In ambulant setting: ability to apply the ambulant EEG device for the duration of the study, either alone or with help of co-habitant if MoCA < 20

Exclusion Criteria

• Failure to give informed consent
• Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
• Known or suspected non-compliance, drug- or medication abuse
• Inability to hear the tones to be applied during sleep in auditory stimulation experiments
• Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
• Regular intake of drugs that may alter the relationship between sleep and outcome variables under investigation (opioids, benzodiazepines and z-drugs (nonbenzodiazepines)).
• Clinically significant concomitant disease states
• Too high (disease) burden for patients
• Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving eye tracking)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Auditory stimulation	Sham condition: Playing no tones during sleep but still recording brain activity (muted tones)
Verum stimulation	Auditory stimulation	Verum condition: Auditory stimulation during sleep

Primary Outcome Measures

Name	Time	Method
Performance change in behavioral/cognitive tasks	measured before and after 4 nights	e.g. reaction time
Electrophysiological markers of brain activity during sleep as measured with EEG	measured during 4 nights	e.g. slow wave activity (SWA)
Change in outcomes of subjective measures	measured before and after 4 nights	e.g. sleepiness (scale from 1 to 10)

Secondary Outcome Measures

Name	Time	Method
Outcomes of other physiological measures during sleep	measured during 4 nights	e.g. muscle activity (EMG)
Outcomes of other physiological measures during behavioral tasks	measured before and after 4 nights	e.g. pupil dilation

Trial Locations

Locations (1)

University Hospital Zurich, Neurology department; 🇨🇭 Zürich, Zurich, Switzerland