Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386497
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-15
Brief Title:
Acceptability of the Somnomat Casa for the Treatment of Parkinsons Disease
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Overnight Treatment of Parkinsons Disease Using Vestibular Stimulation From a Rocking Bed Somnomat Casa - A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Somnomat Casa
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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None