Parkinson's Disease Clinical Trials

Find Parkinson's Disease Clinical Trials Near You

Non-pharmacological Enhancement of Deep Sleep With Auditory Stimulation Versus Sham in People With Parkinson's Disease and Mild Cognitive Impairment Receiving Cognitive Training: A Double-blind Randomized Trial (PD-CogT-Sleep)

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
University Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Simon J. Schreiner, MD
simon.schreiner@usz.ch
+41 43 253 24 18
Backup
Marie Therese Kleinsorge, MD
marie.kleinsorge@usz.ch
+41 43 253 13 10
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Zurich
Collaborators: University Hospital, Zürich

This content was sourced from clinicaltrials.gov