Using a rocking bed to improve sleep in Parkinson's disease patients
Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
This study is testing whether a special rocking bed can help improve sleep and overall well-being for people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Bern and 1 other locations) |
| Trial ID | NCT06386497 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and acceptability of using a rocking bed, known as Somnomat Casa, to provide nocturnal vestibular stimulation for patients with Parkinson's Disease over a two-month period. Twelve participants will receive this treatment in their home environment, and their feedback will be collected through questionnaires and interviews. The study will assess various outcomes, including sleep quality, motor and non-motor symptoms, and overall quality of life, using validated scales and physiological monitoring. Data will be collected before, during, and after the intervention to determine its effectiveness and acceptability.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Parkinson's Disease who experience reduced sleep quality.
Not a fit: Patients with other brain diseases, severe psychiatric conditions, or those who are not fluent in German may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for patients with Parkinson's Disease.
How similar studies have performed: While the approach of using vestibular stimulation for sleep improvement is novel, similar studies have shown promise in enhancing sleep quality in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bern and 1 other locations
- Insel Gruppe AG, University Hospital Bern — Bern, Switzerland (Recruiting)
- ETH Zurich, Sensory-Motor Systems Lab, IRIS — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Lenard Lachenmayer, MD — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Lenard Lachenmayer, MD
- Email: lenard.lachenmayer@insel.ch
- Phone: 31 66 4 12 59
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.