Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT07175012
Brief Summary:
This study will evaluate the effectiveness, safety, and tolerability of a novel wearable device, the ELECTROVEST, designed to improve airway clearance in patients with chronic respiratory diseases. The ELECTROVEST will integrate high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation. This crossover clinical trial will compare the performance of the ELECTROVEST with a standard HFCWO vest (The Vest®) in adult patients. Primary outcomes will include sputum expectoration and patient-reported comfort. The study will aim to determine whether this new system can optimize bronchial hygiene.
Detailed Description:
This is a prospective, crossover pilot study designed to evaluate the safety, efficacy, and tolerability of a novel respiratory therapy device, ELECTROVEST, in adult patients diagnosed with chronic respiratory diseases featuring bronchial hypersecretion, such as COPD, bronchiectasis, cystic fibrosis, and asthma.
ELECTROVEST is a wearable vest that integrates high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrical stimulation (NMES). This dual-action therapy aims to enhance airway clearance while also stimulating respiratory musculature.
The study will enroll 20 patients, using a non-probabilistic, intentional sampling strategy. Each participant will undergo two intervention phases, acting as their own control. The phases are separated by a 30-day washout period to minimize carryover effects.
Phase 1 (ELECTROVEST intervention): Participants receive standard fluid and aerosol therapy followed by vibratory therapy delivered by the ELECTROVEST device. Sessions include:
Warm-up phase: 2 minutes at 4 Hz
Active treatment: 16 minutes at 8 Hz
Cool-down phase: 2 minutes at 4 Hz
Phase 2 (Control intervention): Participants receive the same fluid and aerosol therapy, followed by vibratory therapy using standard HFCWO systems (The Vest® Model 105 ). The session follows:
Warm-up: 2 minutes at 13 Hz
Active treatment: 16 minutes at 20 Hz
Cool-down: 2 minutes at 13 Hz
Both interventions are conducted under clinical supervision. The effects will be assessed through pulmonary function tests, respiratory muscle strength, sputum analysis, oxygenation and hemodynamics, patient-reported symptoms, and blood biomarkers.
Pulmonary function and muscle strength will be measured before and 10 minutes after each intervention (FEV₁, DLCO, PImax, PEmax, SNIP). Sputum production and quality will be assessed by weight and purulence (Murray scale). Exercise tolerance will be evaluated via the 6-minute walk test.
Blood markers will be obtained before and 48 hours after each intervention, including:
Creatine phosphokinase (CPK-MM, CPK-BB)
C-reactive protein (CRP)
Peripheral leukocyte count
Creatinine, urea, albumin
Estimated glomerular filtration rate (eGFR)
Venous lactate
Monitoring during sessions includes:
Oxygen saturation (SpO₂)
Heart rate
Discomfort and dyspnea assessed via a visual analogue scale (VAS, 0-10), recorded at baseline, 5 minutes, and post-treatment.
This trial aims to identify physiological responses, tolerability, and short-term safety signals, while generating preliminary data on the potential dual utility of the ELECTROVEST device as a mucociliary clearance and respiratory muscle stimulation therapy.
Study:
NCT07175012
Study Brief:
Protocol Section:
NCT07175012