Exploring the Recovery Function of Sleep in Neurodegeneration (RFSN)

University of Zurich (UZH)

Status: Enrolling

Conditions: Neurodegenerative Diseases

Treatments: Behavioral: Auditory stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05402488

RFSN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Verum stimulation

Experimental group

Description:

Verum condition: Auditory stimulation during sleep

Treatment:

Behavioral: Auditory stimulation

Sham stimulation

Sham Comparator group

Description:

Sham condition: Playing no tones during sleep but still recording brain activity (muted tones)

Treatment:

Behavioral: Auditory stimulation