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

NCT07441915 | Recruiting

• 1 other identifier: PD-CogT-Sleep
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parkinson's Disease; Mild Cognitive Impairment

Keywords

PD-MCI; Sleep; Parkinson's Disease; Neurodegeneration; Mild Cognitive Impairment; Cognitive Training; Digital Cognitive Training; Auditory Stimulation; Acoustic Stimulation; Randomized Clinical Trial; Wearable Device; Electroencephalography; Blood-based Biomarkers

Outcome Measures

Primary Outcomes (1)

• Additive Effect of PTAS on Cognitive Improvements (Executive Performance) Through Digital Cognitive Training in PD-MCI

  The primary outcome is the change in executive functioning between baseline and follow-up assessments, compared between the CogT+PTAS and CogT+Sham groups. Executive performance will be measured using an equally weighted composite domain score, calculated as the mean of multiple demographically adjusted, standardized z-scores from neuropsychological tests within the executive domain. This composite score captures the multidimensional nature of executive functions and reduces random measurement error.

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

Secondary Outcomes (5)

• Additive Effect of PTAS on Cognitive Improvements (Global Cognitive Performance) Through Digital Cognitive Training in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Additive Effect of PTAS on Cognitive Improvements (Attention and Working Memory) Through Digital Cognitive Training in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Additive Effect of PTAS on Cognitive Improvements (Visuo-Cognitive Performance) Through Digital Cognitive Training in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Additive Effect of PTAS on Cognitive Improvements (Language Performance) Through Digital Cognitive Training in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Effect of PTAS on Blood Neurofilament Light Chain (NfL) Levels in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

Other Outcomes (8)

• Change in Subjective Cognitive Decline (SCD)

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Change in Quality of Life

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

• Exploratory Effect of PTAS on Non-Motor Symptoms in PD-MCI

  Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.

Study Arms (2)

PTAS + Digital Cognitive Training

ACTIVE COMPARATOR

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.

Device: Phase-Targeted Auditory Stimulation (PTAS); Other: Digital Cognitive Training (CogT)

Sham-PTAS + Digital Cognitive Training

SHAM COMPARATOR

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.

Other: Digital Cognitive Training (CogT)

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.

PTAS + Digital Cognitive Training

Digital Cognitive Training (CogT) OTHER

All participants will complete a digital, home-based cognitive training (CogT) program following a standardized schedule.

PTAS + Digital Cognitive Training; Sham-PTAS + Digital Cognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon J. Schreiner, MD

  University Hospital Zurich, University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon J. Schreiner, MD

CONTACT

+41 43 253 24 18; simon.schreiner@usz.ch

Marie Therese Kleinsorge, MD

CONTACT

+41 43 253 13 10; marie.kleinsorge@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 2, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)