Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
Recruiting · NCT06386497 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
Nocturnal translational vestibular stimulation
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Insel Gruppe AG, University Hospital Bern - Bern, Switzerland
- ETH Zurich, Sensory-Motor Systems Lab, IRIS - Zurich, Switzerland