An interventional study of ELECTROVEST and The Vest® Model 105 in COPD (Chronic Obstructive Pulmonary Disease), Cystic Fibrosis (CF) and Bronchiectasis Adult, sponsored by Hospitales Universitarios Virgen del Rocío. Completed at 1 site in Spain. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Hospitales Universitarios Virgen del Rocío · Not applicable, Interventional, and Treatment
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Hospitales Universitarios Virgen del Rocío is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Participants in this arm will receive airway clearance therapy using the ELECTROVEST, a wearable device that combines high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation (EEM). The intervention will be administered alongside standard fluid and aerosol therapy. This phase is designed to evaluate the device's safety, effectiveness, and tolerability.
Device: ELECTROVEST
Participants in this arm will receive standard airway clearance therapy using a high-frequency chest wall oscillation (HFCWO) vest device, either The Vest® Model 105 or the AffloVest®. The therapy will be combined with fluid and aerosol therapy and will serve as the comparator for evaluating the ELECTROVEST intervention. Participants will undergo this treatment after a 30-day washout period.
Device: The Vest® Model 105
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.
Also known as: Electrostimulation Vibratory Vest
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.
Also known as: Standard HFCWO Therapy
Volume of Expectorated Sputum
Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session
Time frame: Immediately post-intervention (within 1 hour)
Discomfort Level (VAS Score)
Subjective discomfort assessed using a 0-10 visual analogue scale (VAS), where 0 indicates no discomfort and 10 indicates maximum discomfort.
Time frame: Immediately after each intervention session
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 measured via spirometry, according to ATS/ERS standards.
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Inspiratory Pressure (PImax)
Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion)
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Expiratory Pressure (PEmax)
Respiratory muscle strength measured in cmH2O using MicroRPM (Carefusion)
Time frame: Baseline and 24-48 hours after each intervention.
Six-Minute Walk Distance (6MWD)
Distance walked in meters during the 6-minute walk test as a measure of functional capacity.
Time frame: Baseline and 24-48 hours after each intervention.
DLCO (Diffusing Capacity for Carbon Monoxide)
Measured using single-breath technique, following ATS/ERS 2017 guidelines.
Time frame: Baseline and 24-48 hours after each intervention.
Inflammatory and Muscle Biomarkers
Blood markers including creatine phosphokinase (CPK) and C-reactive protein (CRP), measured through standard blood analysis.
Time frame: Baseline and 24-48 hours after each intervention.
Maximal Nasal Inspiratory Pressure (SNIP)
Nasal inspiratory pressure assessed using the SNIP test (Sniff Nasal Inspiratory Pressure) to evaluate inspiratory muscle strength. Unit measure cmH₂O.
Time frame: Baseline and 24-48 hours after each intervention.
Estimated Glomerular Filtration Rate (eGFR)
Renal function assessed using estimated glomerular filtration rate (eGFR), calculated using the Cockcroft-Gault formula based on blood creatinine, age, weight, and sex.
Time frame: Baseline and 24-48 hours after each intervention.
Health-Related Quality of Life (CASA-Q)
Health status and cough-related quality of life evaluated using the CASA-Q questionnaire (Cough and Sputum Assessment Questionnaire). Higher scores indicate better outcomes.
Time frame: Baseline and 24-48 hours after each intervention.
Plan to share: Undecided — It is undecided whether individual participant data (IPD) will be shared. The study team is currently evaluating the feasibility of anonymizing and storing IPD in a secure repository in accordance with institutional and ethical guidelines.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Hospitales Universitarios Virgen del Rocío