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

Parkinson Disease Clinical Trial

— Somnomat Casa  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386497
• Other study ID #: 2023-D0100
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Lenard Lachenmayer, MD
• Phone: 31 66 4 12 59
• Email: lenard.lachenmayer[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Insel Gruppe AG, University Hospital Bern	Bern
Switzerland	ETH Zurich, Sensory-Motor Systems Lab, IRIS	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)