Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-27
Brief Title:
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Sponsor:
Physio-Assist
Organization:
Physio-Assist
Study Overview
Official Title:
Evaluation of the Impact of SIMEOX Airway Clearance Medical Device at Home Combined With Remote Physiotherapy on Quality of Life and Pulmonary Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis Compared With Enhanced Standard of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Home-BRAC
Brief Summary:
Bronchiectasis is a chronic lung disease of multiple aetiologies characterised by permanent dilatation of the calibre of a territory of the bronchial tree with impaired mucociliary clearance This alteration causes mucus retention leading to infections and chronic bronchial inflammation Respiratory physiotherapy is one of the cornerstones of the management of these patients in particular to facilitate bronchial drainage In patients with abundant bronchial secretions it is recommended that bronchial drainage sessions be carried out on a daily or more frequent basis which represents a very substantial burden in terms of care In addition access to respiratory physiotherapy is not always easy for patients due to geographical or time constraints or the availability of professionals Moreover few professionals are trained in this specific care for chronic lung diseases
SIMEOX Physio-Assist France is an innovative medical device CE medical mark for draining the bronchial tree By means of a mouthpiece this device generates a succession of very short intermittent negative air pressure pulses which disseminate a pneumatic vibratory signal in the patients bronchial tree modifying the rheological properties of the mucus facilitating the mobilisation of secretions and assisting their transport towards the upper airways
A recent pilot study demonstrated that the use of SIMEOX independently by the patient at home for 3 months combined with remote Physiotherapy 1 session2 weeks provided a very satisfactory bronchial drainage solution for patients satisfaction assessed at 910 by visual analogue scale with an improvement in their quality of life and very good compliance with the device median of 47 sessionsweek
This bronchial drainage strategy requires a long-term assessment
Hypothesis the use of SIMEOX independently by the patient at home could improve long-term quality of life and reduce the rate of pulmonary exacerbations in non-cystic fibrosis non-CF patients with bronchiectasis bronchial dilatation in comparison to Standard of Care SoC
SIMEOX Physio-Assist France is an innovative medical device CE medical mark for draining the bronchial tree By means of a mouthpiece this device generates a succession of very short intermittent negative air pressure pulses which disseminate a pneumatic vibratory signal in the patients bronchial tree modifying the rheological properties of the mucus facilitating the mobilisation of secretions and assisting their transport towards the upper airways
A recent pilot study demonstrated that the use of SIMEOX independently by the patient at home for 3 months combined with remote Physiotherapy 1 session2 weeks provided a very satisfactory bronchial drainage solution for patients satisfaction assessed at 910 by visual analogue scale with an improvement in their quality of life and very good compliance with the device median of 47 sessionsweek
This bronchial drainage strategy requires a long-term assessment
Hypothesis the use of SIMEOX independently by the patient at home could improve long-term quality of life and reduce the rate of pulmonary exacerbations in non-cystic fibrosis non-CF patients with bronchiectasis bronchial dilatation in comparison to Standard of Care SoC
Detailed Description:
Two main objectives will be assessed simultaneously
To compare the effect of SIMEOX combined with remote Physiotherapy with enhanced SoC SoC Remote Physiotherapy on the quality of life related to the respiratory problems of patients at mid term
To compare the effect of SIMEOX combined with remote Physiotherapy with enhanced SoC SoC Remote Physiotherapy on the rate of respiratory exacerbations at long term
To compare the effect of SIMEOX combined with remote Physiotherapy with enhanced SoC SoC Remote Physiotherapy on the quality of life related to the respiratory problems of patients at mid term
To compare the effect of SIMEOX combined with remote Physiotherapy with enhanced SoC SoC Remote Physiotherapy on the rate of respiratory exacerbations at long term
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