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Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
RECRUITINGN/ASponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2024-01-11
Est. completion2025-09-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06386497
Summary
This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease.
Eligibility
Age: 18 Years – 85 YearsHealthy volunteers accepted
Inclusion Criteria: * Informed Consent signed by the subject * PD according to the MDS clinical diagnostic criteria for Parkinson's disease * Suffering from reduced sleep quality as defined by pathological cut-off (score of \> 5) on the Pittsburgh Sleep Quality Index (PSQI) * Patients with stable antiparkinsonian, antidepressant, and sleep medications for six weeks before intervention and maintained on stable medication during the intervention period * Treatment without bilateral deep brain stimulation * Fluent in German Exclusion Criteria: * Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.). * Dementia as defined by a MOCA score lower than 24/30 * Weight \> 150kg * Depression with acute suicidal ideation * Presence of major ongoing psychiatric illness such as acute non-controlled psychosis * Poor general health (e.g. non-controlled diabetes, uncontrolled arterial hypertension, therapy for malignancy) * Inability to follow the procedures of the study, e.g. filling out patient questionnaires due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another interventional trial within the 30 days preceding and during the present study * Participants with PSQI score lower or equal 5
Conditions2
Parkinson DiseaseParkinson's Disease
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Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2024-01-11
Est. completion2025-09-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06386497