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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Phase-Targeted Auditory Stimulation (PTAS)
DeviceParticipants 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 interventionAll participants will complete a digital, home-based cognitive training (CogT) program following a standardized schedule.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PTAS + Digital Cognitive TrainingActive comparator 2 interventions
Group B: Sham-PTAS + Digital Cognitive TrainingSham comparator 1 intervention
Trial outcomes
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.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.Secondary outcomes
1
Additive Effect of PTAS on Cognitive Improvements (Global Cognitive Performance) Through Digital Cognitive Training in PD-MCI
Secondary outcomes include the change in global cognition between baseline and follow-up assessments, compared between the CogT+PTAS and CogT+Sham groups. Global cognition will be measured using an equally weighted composite score across multiple cognitive domains, based on standardized and demographically adjusted neuropsychological test results.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.2
Additive Effect of PTAS on Cognitive Improvements (Attention and Working Memory) Through Digital Cognitive Training in PD-MCI
Change in attention and working memory performance will be compared between groups across time. This domain will be assessed using an equally weighted composite score, calculated from standardized z-scores of multiple neuropsychological tests within the attention and working memory domain.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.3
Additive Effect of PTAS on Cognitive Improvements (Visuo-Cognitive Performance) Through Digital Cognitive Training in PD-MCI
Secondary analyses will assess group differences in changes in visuo-cognitive abilities across time. Visuo-cognition will be captured using an equally weighted composite domain score based on standardized z-scores from relevant neuropsychological tests.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.4
Additive Effect of PTAS on Cognitive Improvements (Language Performance) Through Digital Cognitive Training in PD-MCI
Changes in language function will be compared between the intervention groups from baseline to follow-up. Language outcomes will be assessed using an equally weighted composite score derived from standardized test performance in the language domain.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.Other outcomes
1
Change in Subjective Cognitive Decline (SCD)
Exploratory analyses will assess changes in subjective cognitive decline (SCD) between baseline and follow-up assessments, comparing the CogT+PTAS and CogT+Sham groups. SCD will be measured using standardized self-report questionnaires.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.2
Change in Quality of Life
Changes in quality of life will be explored as an additional outcome comparing both intervention groups across time. Quality of life will be assessed using validated questionnaires completed during or shortly after clinical visits.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.3
Exploratory Effect of PTAS on Non-Motor Symptoms in PD-MCI
Exploratory outcomes include changes in selected non-motor symptoms, such as fatigue, depressive symptoms, sleep disturbances, and daytime sleepiness. Group differences between CogT+PTAS and CogT+Sham will be evaluated using standardized rating scales.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.4
Change in Vigilance and Inhibitory Control
Exploratory analyses will examine whether PTAS has additive effects on vigilance and inhibitory control, assessed through neuropsychological measures comparing changes between the two study groups over time.
Time frame
Assessed at baseline (pre-intervention), after 5 weeks (post-intervention), and 3-month follow-up.Sponsors and contacts
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University of Zurich
Lead sponsor
University Hospital, Zürich
Collaborator
Source ClinicalTrials.gov