RFSN: Exploring the Recovery Function of Sleep in Neurodegeneration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Verum stimulation Verum condition: Auditory stimulation during sleep |
Behavioral: Auditory stimulation
Auditory stimulation during sleep
|
| Sham Comparator: Sham stimulation Sham condition: Playing no tones during sleep but still recording brain activity (muted tones) |
Behavioral: Auditory stimulation
Auditory stimulation during sleep
|
Outcome Measures
Primary Outcome Measures
- Electrophysiological markers of brain activity during sleep as measured with EEG [measured during 4 nights]
e.g. slow wave activity (SWA)
- Performance change in behavioral/cognitive tasks [measured before and after 4 nights]
e.g. reaction time
- Change in outcomes of subjective measures [measured before and after 4 nights]
e.g. sleepiness (scale from 1 to 10)
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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:
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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)).
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Clinically significant concomitant disease states
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Zurich, Neurology department | Zürich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RFSN