Nocturnal translational vestibular… for Parkinson's (NCT06386497)
Improve sleep using vestibular stimulation
- Trial ID
- NCT06386497
- Official Title
- Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
- Goal
- Improve sleep using vestibular stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Study Type
- INTERVENTIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
- Interventions
- Nocturnal translational vestibular stimulation
Summary For Families
It tests whether gentle overnight rocking from a Somnomat Casa bed can improve sleep quality and reduce nighttime fragmentation for people with Parkinson's. The bed delivers slow translational vestibular stimulation to the inner ear, a non-drug way to nudge the brain toward deeper, more consolidated sleep, and the intervention is used while participants stay on their usual Parkinson's, antidepressant, and sleep medications. This is a small feasibility study with about 15 participants, using a noninvasive device and excluding people with bilateral deep brain stimulation. Adults 18 to 85 with Parkinson's by MDS criteria who have poor sleep (PSQI > 5), speak German, are not demented (MoCA ≥ 24), weigh under 150 kg, and have no major psychiatric or other neurological diseases can apply.
Locations
- Insel Gruppe AG, University Hospital Bern, Bern, Switzerland
- ETH Zurich, Sensory-Motor Systems Lab, IRIS, Zurich, Switzerland
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Nocturnal translational vestibular stimulation. It tests whether gentle overnight rocking from a Somnomat Casa bed can improve sleep quality and reduce nighttime fragmentation for people with Parkinson's. The bed delivers slow translational vestibular stimulation to the inner ear, a non-drug way to nudge the brain toward deeper, more consolidated sleep, and the intervention is used while participants stay on their usual Parkinson's, antidepressant, and sleep medications. This is a small feasibility study with about 15 participants, using a noninvasive device and excluding people with bilateral deep brain stimulation. Adults 18 to 85 with Parkinson's by MDS criteria who have poor sleep (PSQI > 5), speak German, are not demented (MoCA ≥ 24), weigh under 150 kg, and have no major psychiatric or other neurological diseases can apply.
- Who can participate?
- Participants must be between 18 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.