Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Nocturnal translational vestibular stimulation
- Registration Number
- NCT06386497
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parkinson's disease patients Nocturnal translational vestibular stimulation All included Parkinson's disease patients
- Primary Outcome Measures
Name Time Method Evaluation of acceptability and feasibility At Visit 2, at the end of the intervention (after 2 months) 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 Outcome Measures
Name Time Method Patients' Global Impression of Change Scale (PGICS) At Final Visit (two months after the intervention) The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time.
Parkinson's Disease Sleep Scale version 2 (PDSS-2) At Final Visit (two months after the intervention) The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. The PDSS-2 covers three domains: motor symptoms at night, PD specific symptoms at night and disturbed sleep.
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) At Final Visit (two months after the intervention) The MDS-UPDRS is a scale used to measure the severity of PD. A higher score denotes greater disability. It includes four parts: mentation, behaviour and mood (MDS-UPDRS I); activities of daily living (MDS-UPDRS II); motor examination MDS-UPDRS III); complication of treatment (MDS-UPDRS IV).
Epworth Sleepiness Scale (ESS) At Final Visit (two months after the intervention) The ESS is a short self-administered questionnaire designed to assess daytime sleepiness. This basic test involves a self-assessment of how likely a person is to fall asleep in eight different situations.
Restless Legs Syndrome Rating Scale (IRLS) At Final Visit (two months after the intervention) IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).
Patients' Global Impression of Severity Scale (PGIS) At Baseline Visit (before the intervention) The Patient Global Impression of Severity scale is a single, self-administered question asking respondents about the severity of their current general condition.
Pittsburgh Sleep Quality Index (PSQI) At Final Visit (two months after the intervention) 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.
Parkinson's disease quality of life questionnaire (PDQ-39) At Final Visit (two months after the intervention) The Parkinson's disease quality of life questionnaire evaluates the disease specific QoL. This questionnaire quantifies disease-specific and disease-referred quality of life in PD patients. In 39 items 8 main dimensions are interrogated (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive impairment, communication and bodily discomfort). Each of these 8 domains contributes equally to a summary index of overall disease specific QoL.
Trial Locations
- Locations (2)
Insel Gruppe AG, University Hospital Bern
🇨ðŸ‡Bern, Switzerland
ETH Zurich, Sensory-Motor Systems Lab, IRIS
🇨ðŸ‡Zürich, Switzerland