Exploring the Recovery Function of Sleep in Neurodegeneration

NCT05402488 | Recruiting

• 1 other identifier: RFSN
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Keywords

Parkinson's Disease; Huntington's Disease; MCI; Neurodegenerative Diseases; Sleep; Auditory Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Outcomes of other physiological measures during sleep

  measured during 4 nights

• Outcomes of other physiological measures during behavioral tasks

  measured before and after 4 nights

Study Arms (2)

Verum stimulation

EXPERIMENTAL

Verum condition: Auditory stimulation during sleep

Behavioral: Auditory stimulation

Sham stimulation

SHAM COMPARATOR

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

Behavioral: Auditory stimulation

Interventions

Auditory stimulation BEHAVIORAL

Auditory stimulation during sleep

Sham stimulation; Verum stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Neurology department

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases; Parkinson Disease; Huntington Disease

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Central Study Contacts

Angelina Maric, Dr. phil.

CONTACT

+41 44 255 86 15; angelina.maric@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: June 2, 2022
• Study Start: March 14, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)