About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Nocturnal translational vestibular stimulation
DeviceNocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of acceptability and feasibility
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
Evaluation of acceptability and feasibility
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
Secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Sponsors and contacts
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
ETH Zurich
Collaborator