Auditory Sleep Stimulation or Sham in People With Parkinson Disease Mild Cognitive Impairment During Cognitive Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich
About this trial
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 criteria
Qualifiers
clinical diagnosis of PD along the MDS criteria (Postuma et al., 2015)
- 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Phase-Targeted Auditory Stimulation (PTAS)
- Digital Cognitive Training (CogT)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Zurich
Lead sponsor
University Hospital, Zürich
Collaborator
Source ClinicalTrials.gov