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

NCT06237348 | Completed

• 1 other identifier: Simeox 1.1 290623
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-cystic Fibrosis Bronchiectasis; Chronic Mucus Hypersecretion

Keywords

NCFB; CMH; Simeox; Airway clearance; ACT; Bronchiectasis; Telecare

Outcome Measures

Primary Outcomes (1)

• 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)

  2 months

Secondary Outcomes (21)

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

  2 months

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

  2 months

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

  2 months

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

  2 months

• To evaluate mucus quality with Simeox therapy during follow-up

  2 months

Study Arms (2)

Simeox

EXPERIMENTAL

Airway clearance device

Device: Simeox; Combination Product: Control

Control

ACTIVE COMPARATOR

Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)

Combination Product: Control

Interventions

Simeox DEVICE

Daily airway clearance therapy at home during 2 months

Simeox

Control COMBINATION_PRODUCT

Daily airway clearance therapy at home during 2 months

Also known as: Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)

Control; Simeox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.

Sponsors & Collaborators

• Physio-Assist: lead
• Medical University of Lodz: collaborator
• University Hospital in Krakow: collaborator

Study Sites (2)

Jagiellonian University Medical College

Krakow, 30-688, Poland

Location

N. Barlicki University Hospital No 1

Lodz, 90-153, Poland

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Wojciech PIOTROWSKI, MD, PhD

  Medical University of Lodz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, parallel, Multicenter Randomized controlled trial,

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: October 15, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

PL (2)