Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nocturnal translational vestibular stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
Overview
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.
Detailed description
Twelve PD patients will receive overnight VS in their familiar home environment for two months via the rocking bed. Participants will be given questionnaires to obtain feedback on the acceptability of the nocturnal intervention device.
Effects on sleep, motor and non-motor symptoms, and quality of life will be assessed using the appropriate validated scales and questionnaires. The corresponding assessments will be performed before, during, and two month after the intervention.
Unobtrusive pressure-sensitive textiles and bioradar will be used to record physiological variables such as body position, movements, breathing rate, and heart rate to correlate them to the clinical assessments as well as to markers obtained from actigraphy devices that the patients will be wearing throughout the study.
The primary feasibility outcomes include rate of accrual and retention, adherence to the protocol, acceptability and satisfaction with intervention using rocking bed specific questionnaires, semi-structured interviews, and data collected automatically from the bed.
To assess the preliminary effectiveness of the intervention the secondary outcomes are the change in subjective sleep quality, daytime sleepiness, PD related sleep disorders, mentation, behaviour, mood, activities of daily living, motor performance, and quality of life.
Interventions
- Device Nocturnal translational vestibular stimulation
Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.
Primary outcome measures
- Evaluation of acceptability and feasibility [Time frame: At Visit 1 (1 month after start of intervention)]
- Evaluation of acceptability and feasibility [Time frame: At Visit 2, at the end of the intervention (after 2 months)]
Secondary outcome measures (12)
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: At Baseline Visit (before the intervention)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: At Visit 1 (1 month after start of intervention)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: At Visit 2, at the end of the intervention (after 2 months)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: At Final Visit (two months after the intervention)]
- Epworth Sleepiness Scale (ESS) [Time frame: At Baseline Visit (before the intervention)]
- Epworth Sleepiness Scale (ESS) [Time frame: At Visit 1 (1 month after start of intervention)]
- Epworth Sleepiness Scale (ESS) [Time frame: At Visit 2, at the end of the intervention (after 2 months)]
- Epworth Sleepiness Scale (ESS) [Time frame: At Final Visit (two months after the intervention)]
- Parkinson's Disease Sleep Scale version 2 (PDSS-2) [Time frame: At Baseline Visit (before the intervention)]
- Parkinson's Disease Sleep Scale version 2 (PDSS-2) [Time frame: At Visit 1 (1 month after start of intervention)]
- Parkinson's Disease Sleep Scale version 2 (PDSS-2) [Time frame: At Visit 2, at the end of the intervention (after 2 months)]
- Parkinson's Disease Sleep Scale version 2 (PDSS-2) [Time frame: At Final Visit (two months after the intervention)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 2 centers
- Insel Gruppe AG, University Hospital Bern — Bern
- ETH Zurich, Sensory-Motor Systems Lab, IRIS — Zurich
Identifiers
NCT: NCT06386497 · 2023-D0100