Exploring the Recovery Function of Sleep in Neurodegeneration

Neurodegenerative Diseases Clinical Trial

— RFSN  

Official title:

Exploring the Recovery Function of Sleep in Neurodegeneration - an Observational Cross-Sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402488
• Other study ID #: RFSN
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: June 2026

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: Angelina Maric, Dr. phil.
• Phone: +41 44 255 86 15
• Email: angelina.maric[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nerve Degeneration
• Neurodegenerative Diseases

Intervention

Behavioral:
• Auditory stimulation
Auditory stimulation during sleep

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Neurology department	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrophysiological markers of brain activity during sleep as measured with EEG	e.g. slow wave activity (SWA)	measured during 4 nights
Primary	Performance change in behavioral/cognitive tasks	e.g. reaction time	measured before and after 4 nights
Primary	Change in outcomes of subjective measures	e.g. sleepiness (scale from 1 to 10)	measured before and after 4 nights
Secondary	Outcomes of other physiological measures during sleep	e.g. muscle activity (EMG)	measured during 4 nights
Secondary	Outcomes of other physiological measures during behavioral tasks	e.g. pupil dilation	measured before and after 4 nights