Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH

Physio-Assist50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-cystic Fibrosis Bronchiectasis Chronic Mucus Hypersecretion

Interventions

SimeoxDEVICE

Daily airway clearance therapy at home during 2 months

ControlCOMBINATION_PRODUCT

Daily airway clearance therapy at home during 2 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD * Overproduction of mucus (ie: estimated bronchorrhea \>10mL/day). * Pulmonary exacerbation (in- or outpatients) * Age \> 18 years old * Patient able to understand the study and to perform the 2-month follow up visit Exclusion Criteria: * Pneumothorax/pneumo-mediastinum in the six months prior hospitalization * Recent episode of severe haemoptysis * Unstable severe cardiac disease or hemodynamic instability * Cystic fibrosis or COPD as dominant diagnosis * Patient on lung transplant list * Severe lung injuries * Recent lung surgery * Inhalation support (continuous ventilatory support) * Tracheostomy * Uncontrolled GERD * Any contraindication to an instrumental bronchial clearance technique (up to the investigator) * Inability to perform PFT or 6MWT * Patient not available or wishing to move to a different region within 2 months of inclusion * Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures. * Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator

Locations (2)

Jagiellonian University Medical College

Krakow, Poland

N. Barlicki University Hospital No 1

Lodz, Poland

Outcomes

Primary Outcomes

To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up

The evolution of device adherence will be described by % of self-reported sessions (0-1; 2-3; 4-7/week) by the patient over the 2-month FU (1 week, 2 weeks, 1 month and 2 months)

Time frame: 2 months

Secondary Outcomes

To describe Simeox therapy settings (program selection) during follow-up

Simeox settings will be described by program selection (1, 2 or 3)

Time frame: 2 months

To describe Simeox therapy settings (intensity) during follow-up

Simeox settings will be described by intensity (25%, 50%, 75% or 100%)

Time frame: 2 months

To describe Simeox therapy settings (number of session) during follow-up

Simeox settings will be described by the number of sessions per day

Time frame: 2 months

To describe Simeox therapy settings (session duration) during follow-up

Simeox settings will be described by the session duration in minutes

Time frame: 2 months

To evaluate mucus quality with Simeox therapy during follow-up

Mucus quality will be evaluated during follow-up with a score from 1 to 4 (abondant - Scanty)

Time frame: 2 months

To evaluate breathing quality with Simeox therapy during follow-up

Breathing quality level will be evaluated during follow-up with a score from 1 to 4 (very good - very poor)

Data from ClinicalTrials.gov

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