Sound-based sleep stimulation to boost brain training in Parkinson's with mild cognitive impairment
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)
This test will see if playing gentle, phase-targeted sounds during sleep together with a five-week home cognitive training program helps people with Parkinson's disease and mild cognitive impairment get more benefit from training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT07441915 on ClinicalTrials.gov |
What this trial studies
People with Parkinson's disease often have sleep disturbances and early cognitive decline, so this randomized, double-blind trial adds nightly phase-targeted auditory stimulation (PTAS) or a sham to a five-week home digital cognitive training program. Participants use a bedside sleep device that plays soft sounds aimed at enhancing deep (slow-wave) sleep, while completing computerized cognitive exercises at home. Neither participants nor researchers know who receives real versus sham stimulation. Cognitive testing and an overnight sleep assessment at University Hospital Zurich are done before and after the intervention and again three months later to determine whether improved deep sleep increases training gains and slows cognitive decline.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of Parkinson's disease who meet MDS criteria for level‑I mild cognitive impairment (MoCA 18–26), have a stable home situation and stable medications, sufficient German language skills, and the ability to use the sleep device and complete home cognitive training are ideal.
Not a fit: People with more advanced dementia, unstable medical or medication status, inability to use the device or follow German-language procedures, or those unable to travel to Zurich for the overnight assessments are unlikely to benefit.
Why it matters
Potential benefit: If successful, combining sleep-targeted sounds with cognitive training could strengthen memory and thinking and slow cognitive decline in Parkinson's disease.
How similar studies have performed: Previous studies in healthy older adults and non‑PD MCI populations have shown that phase‑targeted auditory stimulation can boost slow‑wave sleep and memory consolidation, but this approach is novel and less tested in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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 * frequent (i.e. weekly) Non-REM sleep parasomnia (Sleep disorders typically associated with PD will not lead to exclusion, i.e. REM sleep behavior disorder, insomnia, nocturnal PD symptoms.) 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 * known or suspected non-compliance Cognition \& informed consent: * inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits * failure to give informed consent Other studies: * participation in another study with investigational interventions within 30 days (PTAS) or 1 year (CogT) preceding and during the present study * previous enrolment in the current study * enrolment of the investigator, his/her family members, employees and other dependent persons Special events / behavior with impact on circadian rhythm, sleep, or cognition: * shift work (work during the night) * travelling more than 2 time zones in the last month before intervention starts or during intervention (start of intervention will be adapted to fit with this criteria) * planned medical intervention of substantial relevance, e.g. surgery, during intervention (routine assessments, e.g. check-ups will be allowed) Pregnancy: * women who are pregnant or breastfeeding, * intention to become pregnant during the course of the study, * lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
Where this trial is running
Zurich, Canton of Zurich
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Simon J. Schreiner, MD — University Hospital Zurich, University of Zurich
- Study coordinator: Simon J. Schreiner, MD
- Email: simon.schreiner@usz.ch
- Phone: +41 43 253 24 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.