Exploring the Recovery Function of Sleep in Neurodegeneration (RFSN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurodegenerative Diseases
• Intervention / Treatment: Behavioral: Auditory stimulation

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelina Maric, Dr. phil.; Phone Number: +41 44 255 86 15; Email: angelina.maric@usz.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich, Neurology Department
      • Contact: Angelina Maric, PhD; Phone Number: +41 44 255 86 15; Email: angelina.maric@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Parkinson's Disease; MCI; Sleep; Neurodegenerative Diseases; Huntington's Disease; Auditory Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurodegenerative Diseases; Nerve Degeneration
• Other Study ID Numbers: RFSN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No