Exploring the Recovery Function of Sleep in Neurodegeneration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurodegenerative Diseases

Intervention / Treatment
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* Behavioral: Auditory stimulation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum stimulation<br>Verum condition: Auditory stimulation during sleep | Behavioral: Auditory stimulation<br>* Auditory stimulation during sleep<br>|
| Sham Comparator: Sham stimulation<br>Sham condition: Playing no tones during sleep but still recording brain activity (muted tones) | Behavioral: Auditory stimulation<br>* Auditory stimulation during sleep<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of other physiological measures during sleep | e.g. muscle activity (EMG) | measured during 4 nights | 
| Outcomes of other physiological measures during behavioral tasks | e.g. pupil dilation | measured before and after 4 nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Huntington's Disease, MCI, Neurodegenerative Diseases, Sleep, Auditory Stimulation