Auditory Sleep Stimulation or Sham in People With Parkinson Disease Mild Cognitive Impairment During Cognitive Training

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Parkinson's Disease, Mild Cognitive Impairment

In brief

People with Parkinson's disease are at higher risk of cognitive decline, and current treatments cannot fully prevent this. This study explores non-drug ways to support brain function. Intervention: Participants will complete a 5-week cognitive training program at home ("brain fitness"). In addition, they will use a sleep device at night that plays soft sounds to improve deep sleep; Half of the participants will actually receive these sounds (auditory stimulation), while the other half will receive a sham (placebo) version - neither the participants nor the researchers will know the group assignment. Assessments will take place before and after the intervention, and again three months later, including one overnight stay at University Hospital Zurich per assessment. The goal is to find out whether improving deep sleep can boost the benefits of cognitive training and help slow cognitive decline in Parkinson's disease.

Key facts

Study ID: NCT07441915
Run by: University of Zurich
People needed: 50
Starts: 2026-04-22
Expected to finish: 2027-12-01
Last updated by the study team: 2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

clinical diagnosis of PD along the MDS criteria (Postuma et al., 2015)
MCI according to the MDS criteria, level I (Litvan et al., 2012):
- cognitive decline: Gradual decline, in the context of established PD, in cognitive ability reported by either the patient or informant, or observed by the clinician, AND
- MoCA ≤ 26 and ≥ 18 (Hoops et al., 2009)
stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
ability to apply the sleep intervention for the duration of study, either alone or with assistance of a co-habitant if needed
ability to apply the CogT intervention for the duration of study
sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
dosing of dopaminergic and other PD treatment must have been stable for at least 14 days prior to the intervention period and will be expected to remain stable until the end of the study.

You may not qualify if…

Diagnosis/Comorbidities:
clinical diagnosis of dementia (cognitive impairment sufficient to interfere with independence in everyday activities, i.e. "major neurocognitive disorder", DSM-5)
known presence of neurologic (other than PD) or psychiatric disorder
Parkinsonism without response to levodopa; atypical Parkinsonian syndromes as assessed from medical history and clinical examination
severe medical conditions (for example, renal insufficiency, liver failure, or congestive heart failure) as assessed in the semi-structured screening interview
regular use of benzodiazepines and other central nervous system (CNS)-depressant substances as assessed in the semi-structured screening interview
known or suspected drug- or medication abuse as assessed in the semi-structured screening interview
substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day) as assessed in the semi-structured screening interview
Sleep disorders that could interfere with the sleep intervention:
obstructive sleep apnea with apnea-hypopnea index (AHI)>15, apnea-related NREM sleep fragmentation, and indication for treatment (in turn, primarily REM-related sleep apnea, not requiring specific treatment may be considered eligible); or use of continuous positive airway pressure (CPAP)
Restless Legs Syndrome
frequent (i.e. weekly) Non-REM sleep parasomnia (Sleep disorders typically associated with PD will not lead to exclusion, i.e. REM sleep behavior disorder, insomnia, nocturnal PD symptoms.)
PTAS:
inability to hear the tones produced by the sleep headband (TOSOO Axora device)
non-responder to PTAS during screening (PTAS does not evoke a discernable auditory evoked potential AEP)
skin disorders/problems/allergies in face/ear area that could worsen with electrode application
known or suspected non-compliance
Cognition \& informed consent:
inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
failure to give informed consent
Other studies:
participation in another study with investigational interventions within 30 days (PTAS) or 1 year (CogT) preceding and during the present study
previous enrolment in the current study
enrolment of the investigator, his/her family members, employees and other dependent persons
Special events / behavior with impact on circadian rhythm, sleep, or cognition:

Where it is running

University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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