Exploring the Recovery Function of Sleep in Neurodegeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration

NCT03353207

REM Sleep Behavior Disorder Neurodegenerative Diseases

COMPLETED

Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder

NCT04048603

REM Sleep Behavior Disorder Neurodegeneration

UNKNOWN

Infra-slow Oscillations During Sleep

NCT02532608

Healthy Subjects Restless Legs Syndrome Periodic Limb Movements During Sleep

COMPLETED NA

Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness

NCT05802524

Consciousness Disorder Cognitive Impairment

COMPLETED

Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD

NCT03671772

REM Sleep Behavior Disorder Neurodegeneration

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurodegenerative Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Verum stimulation

Verum condition: Auditory stimulation during sleep

Group Type EXPERIMENTAL

Auditory stimulation

Intervention Type BEHAVIORAL

Auditory stimulation during sleep

Sham stimulation

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

Group Type SHAM_COMPARATOR

Auditory stimulation

Intervention Type BEHAVIORAL

Auditory stimulation during sleep

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Auditory stimulation

Auditory stimulation during sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes