Clinical trial NCT06386497: Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
Official title: Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Vestibular Stimulation
Sleep quality
Rocking bed
Feasibility
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2024-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Evaluation of acceptability and feasibility
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Evaluation of acceptability and feasibility
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At Baseline Visit (before the intervention)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At Final Visit (two months after the intervention)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At Baseline Visit (before the intervention)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At Final Visit (two months after the intervention)
measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2)
timeFrame: At Baseline Visit (before the intervention)
measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2)
timeFrame: At Final Visit (two months after the intervention)
measure: Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: At Baseline Visit (before the intervention)
measure: Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: At Final Visit (two months after the intervention)
measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: At Baseline Visit (before the intervention)
measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: At Final Visit (two months after the intervention)
measure: Parkinson's disease quality of life questionnaire (PDQ-39)
timeFrame: At Baseline Visit (before the intervention)
measure: Parkinson's disease quality of life questionnaire (PDQ-39)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Parkinson's disease quality of life questionnaire (PDQ-39)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Parkinson's disease quality of life questionnaire (PDQ-39)
timeFrame: At Final Visit (two months after the intervention)
measure: Patients' Global Impression of Severity Scale (PGIS)
timeFrame: At Baseline Visit (before the intervention)
measure: Patients' Global Impression of Change Scale (PGICS)
timeFrame: At Visit 1 (1 month after start of intervention)
measure: Patients' Global Impression of Change Scale (PGICS)
timeFrame: At Visit 2, at the end of the intervention (after 2 months)
measure: Patients' Global Impression of Change Scale (PGICS)
timeFrame: At Final Visit (two months after the intervention)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Insel Gruppe AG, University Hospital Bern
city: Zürich
country: Switzerland
facility: ETH Zurich, Sensory-Motor Systems Lab, IRIS
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Lenard Lachenmayer, MD
role: PRINCIPAL_INVESTIGATOR
References: