Skip to content

Exploring the Recovery Function of Sleep in Neurodegeneration

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05402488
Acronym
RFSN
Enrollment
200
Registered
2022-06-02
Start date
2022-03-14
Completion date
2026-06-30
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Diseases

Keywords

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

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.

Interventions

Auditory stimulation during sleep

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Electrophysiological markers of brain activity during sleep as measured with EEGmeasured during 4 nightse.g. slow wave activity (SWA)
Performance change in behavioral/cognitive tasksmeasured before and after 4 nightse.g. reaction time
Change in outcomes of subjective measuresmeasured before and after 4 nightse.g. sleepiness (scale from 1 to 10)

Secondary

MeasureTime frameDescription
Outcomes of other physiological measures during sleepmeasured during 4 nightse.g. muscle activity (EMG)
Outcomes of other physiological measures during behavioral tasksmeasured before and after 4 nightse.g. pupil dilation

Countries

Switzerland

Contacts

Primary ContactAngelina Maric, Dr. phil.
angelina.maric@usz.ch+41 44 255 86 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026