Back to resultsExploring the Recovery Function of Sleep in Neurodegeneration (RFSN)
Primary Purpose
Neurodegenerative Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Auditory stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Neurodegenerative Diseases focused on measuring Parkinson's Disease, Huntington's Disease, MCI, Neurodegenerative Diseases, Sleep, Auditory Stimulation
Eligibility 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:
- 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)
Sites / Locations
- University Hospital Zurich, Neurology departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Verum stimulation
Sham stimulation
Arm Description
Verum condition: Auditory stimulation during sleep
Sham condition: Playing no tones during sleep but still recording brain activity (muted tones)
Outcomes
Primary Outcome Measures
Electrophysiological markers of brain activity during sleep as measured with EEG
e.g. slow wave activity (SWA)
Performance change in behavioral/cognitive tasks
e.g. reaction time
Change in outcomes of subjective measures
e.g. sleepiness (scale from 1 to 10)
Secondary Outcome Measures
Outcomes of other physiological measures during sleep
e.g. muscle activity (EMG)
Outcomes of other physiological measures during behavioral tasks
e.g. pupil dilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05402488
Brief Title
Exploring the Recovery Function of Sleep in Neurodegeneration
Acronym
RFSN
Official Title
Exploring the Recovery Function of Sleep in Neurodegeneration - an Observational Cross-Sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Diseases
Keywords
Parkinson's Disease, Huntington's Disease, MCI, Neurodegenerative Diseases, Sleep, Auditory Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
During data collection, participants will be blinded to the condition, i.e. sham or verum stimulation. All experimenters will be blind for processing and analysis of outcome measures.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum stimulation
Arm Type
Experimental
Arm Description
Verum condition: Auditory stimulation during sleep
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham condition: Playing no tones during sleep but still recording brain activity (muted tones)
Intervention Type
Behavioral
Intervention Name(s)
Auditory stimulation
Intervention Description
Auditory stimulation during sleep
Primary Outcome Measure Information:
Title
Electrophysiological markers of brain activity during sleep as measured with EEG
Description
e.g. slow wave activity (SWA)
Time Frame
measured during 4 nights
Title
Performance change in behavioral/cognitive tasks
Description
e.g. reaction time
Time Frame
measured before and after 4 nights
Title
Change in outcomes of subjective measures
Description
e.g. sleepiness (scale from 1 to 10)
Time Frame
measured before and after 4 nights
Secondary Outcome Measure Information:
Title
Outcomes of other physiological measures during sleep
Description
e.g. muscle activity (EMG)
Time Frame
measured during 4 nights
Title
Outcomes of other physiological measures during behavioral tasks
Description
e.g. pupil dilation
Time Frame
measured before and after 4 nights
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Maric, Dr. phil.
Phone
+41 44 255 86 15
Email
angelina.maric@usz.ch
Facility Information:
Facility Name
University Hospital Zurich, Neurology department
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Maric, PhD
Phone
+41 44 255 86 15
Email
angelina.maric@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Exploring the Recovery Function of Sleep in Neurodegeneration
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