NCT06386497 Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
| NCT ID | NCT06386497 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-01-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Lenard Lachenmayer, MD
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06386497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386497 currently recruiting?
Yes, NCT06386497 is actively recruiting participants. Contact the research team at lenard.lachenmayer@insel.ch for enrollment information.
Where is the NCT06386497 trial being conducted?
This trial is being conducted at Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT06386497 clinical trial?
NCT06386497 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Lenard Lachenmayer, MD at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 15 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.