Asthma Bronchiale, Bronchiectasis Adult, COPD (Chronic Obstructive Pulmonary Disease), Cystic Fibrosis (CF)
Conditions
Keywords
Electrostimulation, High-Frequency Chest Wall Oscillation (HFCW, Airway Clearance, Chronic Respiratory Diseas, Respiratory Physiotherapy
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.
Interventions
DEVICEELECTROVEST
A wearable vest device that delivers airway clearance therapy through high-frequency chest wall oscillation (HFCWO) combined with surface neuromuscular electrostimulation (EEM). The session includes a 2-minute warm-up phase at 4 Hz, 16 minutes of active stimulation at 8 Hz, and a 2-minute recovery phase at 4 Hz (total duration: 20 minutes). The intervention is administered during supervised physiotherapy sessions to promote mucociliary clearance and respiratory muscle activation in patients with chronic respiratory diseases.
DEVICEThe Vest® Model 105
A conventional airway clearance therapy using a commercial high-frequency chest wall oscillation (HFCWO) device (The Vest® Model 105 or AffloVest®). The session includes a 2-minute warm-up phase at 13 Hz, 16 minutes of treatment at 20 Hz, and a 2-minute cool-down at 13 Hz (total duration: 20 minutes). This intervention serves as the active comparator in the crossover trial.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Hospitales Universitarios Virgen del Rocío
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. No masking was applied to participants, care providers, investigators, or outcome assessors due to the nature of the interventions.
Intervention model description
This is a randomized, open-label, two-period crossover trial. Each participant will undergo two treatment phases: one with the investigational device (ELECTROVEST) and one with the standard HFCWO vest (The Vest®). A 30-day washout period will separate the two phases. Each participant will serve as their own control, allowing for intra-individual comparisons of outcomes such as sputum production, pulmonary function, respiratory muscle strength, and tolerability.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Chronic Respiratory Diseases Diagnosed with chronic respiratory disease with bronchial hypersecretion: COPD, cystic fibrosis, bronchiectasis, or asthma * Age \>16 years * Clinically stable (no exacerbations in past 4 weeks)
Exclusion criteria
* Risk of pneumothorax and/or barotrauma * Risk or history of hemoptysis * On active waiting list for lung transplant or surgery * Musculoskeletal or other limiting condition * Diagnosis of osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Expectorated Sputum | Immediately post-intervention (within 1 hour) | Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session |
| Discomfort Level (VAS Score) | Immediately after each intervention session | Subjective discomfort assessed using a 0-10 visual analogue scale (VAS), where 0 indicates no discomfort and 10 indicates maximum discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Expiratory Pressure (PEmax) | Baseline and 24-48 hours after each intervention. | Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion) |
| Six-Minute Walk Distance (6MWD) | Baseline and 24-48 hours after each intervention. | Distance walked in meters during the 6-minute walk test as a measure of functional capacity. |
| DLCO (Diffusing Capacity for Carbon Monoxide) | Baseline and 24-48 hours after each intervention. | Measured using single-breath technique, following ATS/ERS 2017 guidelines. |
| Forced Expiratory Volume in 1 Second (FEV1) | Baseline and 24-48 hours after each intervention. | FEV1 measured via spirometry, according to ATS/ERS standards. |
| Maximal Nasal Inspiratory Pressure (SNIP) | Baseline and 24-48 hours after each intervention. | Nasal inspiratory pressure assessed using the SNIP test (Sniff Nasal Inspiratory Pressure) to evaluate inspiratory muscle strength. Unit measure cmH₂O. |
| Estimated Glomerular Filtration Rate (eGFR) | Baseline and 24-48 hours after each intervention. | Renal function assessed using estimated glomerular filtration rate (eGFR), calculated using the Cockcroft-Gault formula based on blood creatinine, age, weight, and sex. |
| Health-Related Quality of Life (CASA-Q) | Baseline and 24-48 hours after each intervention. | Health status and cough-related quality of life evaluated using the CASA-Q questionnaire (Cough and Sputum Assessment Questionnaire). Higher scores indicate better outcomes. |
| Inflammatory and Muscle Biomarkers | Baseline and 24-48 hours after each intervention. | Blood markers including creatine phosphokinase (CPK) and C-reactive protein (CRP), measured through standard blood analysis. |
| Maximal Inspiratory Pressure (PImax) | Baseline and 24-48 hours after each intervention. | Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion) |
Countries
Spain
Outcome results
None listed