Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Device: Nocturnal translational vestibular stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06386497

2023-D0100

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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