Actively Recruiting
Auditory Sleep Stimulation or Sham in People With Parkinson Disease Mild Cognitive Impairment During Cognitive Training
Led by University of Zurich · Updated on 2026-04-30
50
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Auditory Sleep Stimulation or Sham in People With Parkinson Disease Mild Cognitive Impairment During Cognitive Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Parkinson's disease according to MDS criteria
- Mild cognitive impairment (MCI) meeting MDS level I criteria
- Cognitive decline reported by patient, informant, or clinician
- Montreal Cognitive Assessment (MoCA) score between 18 and 26
- Stable home situation allowing reliable intervention application
- Ability to use the sleep device and cognitive training for the study duration
- Sufficient German language skills to follow procedures and answer questions
- Stable dopaminergic and other Parkinson's treatments for at least 14 days before intervention and expected stability during study
You will not qualify if you...
- Diagnosis of dementia affecting daily independence
- Other neurologic or psychiatric disorders besides Parkinson's
- Parkinsonism not responsive to levodopa or atypical Parkinsonian syndromes
- Severe medical conditions such as renal, liver, or heart failure
- Regular use of benzodiazepines or other central nervous system depressants
- Known or suspected drug or medication abuse
- Substance or alcohol abuse exceeding specified limits
- Obstructive sleep apnea with apnea-hypopnea index over 15 or CPAP use
- Restless Legs Syndrome
- Frequent Non-REM sleep parasomnia
- Inability to hear tones from the sleep headband device
- Non-responder to auditory stimulation during screening
- Skin problems in face or ear area that could worsen with electrodes
- Known or suspected non-compliance
- Inability to follow study procedures or give informed consent
- Participation in other investigational studies recently or currently
- Shift work involving night shifts
- Recent or planned travel across more than 2 time zones
- Planned major medical interventions during study
- Women who are pregnant, breastfeeding, planning pregnancy, or lacking safe contraception
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
Research Team
S
Simon J. Schreiner, MD
CONTACT
M
Marie Therese Kleinsorge, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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