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

NCT06386497 | Recruiting

• 1 other identifier: 2023-D0100
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Vestibular Stimulation; Sleep quality; Rocking bed; Feasibility

Outcome Measures

Primary Outcomes (2)

• Evaluation of acceptability and feasibility

  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").

  At Visit 1 (1 month after start of intervention)

• Evaluation of acceptability and feasibility

  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").

  At Visit 2, at the end of the intervention (after 2 months)

Secondary Outcomes (28)

• Pittsburgh Sleep Quality Index (PSQI)

  At Baseline Visit (before the intervention)

• Pittsburgh Sleep Quality Index (PSQI)

  At Visit 1 (1 month after start of intervention)

• Pittsburgh Sleep Quality Index (PSQI)

  At Visit 2, at the end of the intervention (after 2 months)

• Pittsburgh Sleep Quality Index (PSQI)

  At Final Visit (two months after the intervention)

• Epworth Sleepiness Scale (ESS)

  At Baseline Visit (before the intervention)

Study Arms (1)

Parkinson's disease patients

EXPERIMENTAL

All included Parkinson's disease patients

Device: Nocturnal translational vestibular stimulation

Interventions

Nocturnal translational vestibular stimulation DEVICE

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

Parkinson's disease patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• ETH Zurich: collaborator

Study Sites (2)

Insel Gruppe AG, University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

ETH Zurich, Sensory-Motor Systems Lab, IRIS

Zurich, 8092, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Lenard Lachenmayer, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lenard Lachenmayer, MD

CONTACT

31 66 4 12 59; lenard.lachenmayer@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: January 11, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)