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

Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Nocturnal translational vestibular stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lenard Lachenmayer, MD; Phone Number: +41 31 66 4 12 59; Email: lenard.lachenmayer@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Insel Gruppe AG, University Hospital Bern
    • Contact: Lenard Lachenmayer, MD; Phone Number: +41 31 664 12 59; Email: lenard.lachenmayer@insel.ch
  • Zurich, Switzerland, 8092
    • Not yet recruiting
    • ETH Zurich, Sensory-Motor Systems Lab, IRIS
    • Contact: Robert Riener, Prof.; Phone Number: +41 44 632 66 79; Email: robert.riener@hest.ethz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's disease patients; All included Parkinson's disease patients	Device: Nocturnal translational vestibular stimulation; Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	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.	At Baseline Visit (before the intervention)
Pittsburgh Sleep Quality Index (PSQI)	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.	At Visit 1 (1 month after start of intervention)
Pittsburgh Sleep Quality Index (PSQI)	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.	At Visit 2, at the end of the intervention (after 2 months)
Pittsburgh Sleep Quality Index (PSQI)	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.	At Final Visit (two months after the intervention)
Epworth Sleepiness Scale (ESS)	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.	At Baseline Visit (before the intervention)
Epworth Sleepiness Scale (ESS)	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.	At Visit 1 (1 month after start of intervention)
Epworth Sleepiness Scale (ESS)	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.	At Visit 2, at the end of the intervention (after 2 months)
Epworth Sleepiness Scale (ESS)	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.	At Final Visit (two months after the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)	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.	At Baseline Visit (before the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)	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.	At Visit 1 (1 month after start of intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)	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.	At Visit 2, at the end of the intervention (after 2 months)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)	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.	At Final Visit (two months after the intervention)
Restless Legs Syndrome Rating Scale (IRLS)	IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).	At Baseline Visit (before the intervention)
Restless Legs Syndrome Rating Scale (IRLS)	IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).	At Visit 1 (1 month after start of intervention)
Restless Legs Syndrome Rating Scale (IRLS)	IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).	At Visit 2, at the end of the intervention (after 2 months)
Restless Legs Syndrome Rating Scale (IRLS)	IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).	At Final Visit (two months after the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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).	At Baseline Visit (before the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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).	At Visit 1 (1 month after start of intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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).	At Visit 2, at the end of the intervention (after 2 months)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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).	At Final Visit (two months after the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)	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.	At Baseline Visit (before the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)	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.	At Visit 1 (1 month after start of intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)	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.	At Visit 2, at the end of the intervention (after 2 months)
Parkinson's disease quality of life questionnaire (PDQ-39)	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.	At Final Visit (two months after the intervention)
Patients' Global Impression of Severity Scale (PGIS)	The Patient Global Impression of Severity scale is a single, self-administered question asking respondents about the severity of their current general condition.	At Baseline Visit (before the intervention)
Patients' Global Impression of Change Scale (PGICS)	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.	At Visit 1 (1 month after start of intervention)
Patients' Global Impression of Change Scale (PGICS)	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.	At Visit 2, at the end of the intervention (after 2 months)
Patients' Global Impression of Change Scale (PGICS)	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.	At Final Visit (two months after the intervention)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: ETH Zurich
• Investigators: Principal Investigator: Lenard Lachenmayer, MD, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Sleep quality; Vestibular Stimulation; Rocking bed
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parkinsonian Disorders; Basal Ganglia Diseases; Sleep Initiation and Maintenance Disorders; Parkinson Disease
• Other Study ID Numbers: 2023-D0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No