Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237348
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-11
Brief Title:
Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
Sponsor:
Physio-Assist
Organization:
Physio-Assist
Study Overview
Official Title:
Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This pilot RCT will assess benefits of Simeox technology on lung function respiratory symptoms health-related quality of life subjective efficiency device adherence at home Patient satisfaction tolerance safety and telecare feasibility
Detailed Description:
Non-cystic fibrosis bronchiectasis NCFB is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations Chest physiotherapy is one of the cornerstones of the management of NCFB patients particularly to facilitate airway clearance In NCFB patients with chronic mucus hypersecretion CMH it is recommended that airway clearance sessions be carried out daily or several times a day which represents a very significant burden of care Moreover access to respiratory physiotherapy for patients can be limited due to several causes geographical time or healthcare professional availability constraints In addition few healthcare professionals are trained for bronchial drainage especially with airway clearance devices
SIMEOX Physio-Assist France is an innovative medical device CE medical mark for mucus clearance The device is connected to patient mouth with an expiratory kit circuit When the patient starts up the device during exhalation only SIMEOX disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration After device training with respiratory physiotherapist patients can be treated at hospital and use SIMEOX in autonomy at home Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals
The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation in- or outpatients in comparison to standard of care
SIMEOX Physio-Assist France is an innovative medical device CE medical mark for mucus clearance The device is connected to patient mouth with an expiratory kit circuit When the patient starts up the device during exhalation only SIMEOX disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration After device training with respiratory physiotherapist patients can be treated at hospital and use SIMEOX in autonomy at home Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals
The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation in- or outpatients in comparison to standard of care
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