ELECTROVEST: Electro-Stimulation Vibratory Vest for Pulmonary Rehabilitation in Patients With Chronic Respiratory Diseases

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.

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