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

Sponsor
University of Zurich
Study ID
NCT07441915
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase-Targeted Auditory Stimulation (PTAS) — DEVICE
    Participants will receive Phase-Targeted Auditory Stimulation (PTAS) during sleep delivered via a wearable device to enhance slow-wave activity in sleep.
  • Digital Cognitive Training (CogT) — OTHER
    All participants will complete a digital, home-based cognitive training (CogT) program following a standardized schedule.

Study Details

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 Dates

First listed
Mar 2, 2026
Start date
Apr 22, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PTAS + Digital Cognitive Training
    Participants in this arm will receive active phase-targeted auditory stimulation during sleep. In addition, all participants will complete an identical digital, home-based cognitive training program following the same study schedule and procedures.
  • Sham Comparator: Sham-PTAS + Digital Cognitive Training
    Participants in this control arm will receive sham PTAS using the same device and identical procedures as in the active condition, but without inducing slow-wave enhancement. All participants will also complete the same digital, home-based cognitive training program.

Primary Outcome Measure

Additive Effect of PTAS on Cognitive Improvements (Executive Performance) Through Digital Cognitive Training in PD-MCI [ Time Frame: Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up. ]

Central Contacts

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