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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.