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

NCT ID: NCT06386497

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2025-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Parkinson's disease patients

All included Parkinson's disease patients

Group Type: EXPERIMENTAL

Nocturnal translational vestibular stimulation

Intervention Type: DEVICE

Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.

Interventions

Nocturnal translational vestibular stimulation

Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ETH Zurich

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenard Lachenmayer, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Insel Gruppe AG, University Hospital Bern

Bern, , Switzerland

Site Status: RECRUITING

ETH Zurich, Sensory-Motor Systems Lab, IRIS

Zurich, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Central Contacts

Lenard Lachenmayer, MD

Role: CONTACT

lenard.lachenmayer@insel.ch

31 66 4 12 59 ext. +41

Facility Contacts

Lenard Lachenmayer, MD

Role: primary

lenard.lachenmayer@insel.ch

31 664 12 59 ext. +41

Robert Riener, Prof.

Role: primary

robert.riener@hest.ethz.ch

44 632 66 79 ext. +41

Other Identifiers

2023-D0100

Identifier Type: -

Identifier Source: org_study_id