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

NCT ID: NCT07175012

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2025-05-20

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Cystic Fibrosis (CF); Bronchiectasis Adult; Asthma Bronchiale

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ELECTROVEST Intervention

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.

Group Type: EXPERIMENTAL

ELECTROVEST

Intervention Type: DEVICE

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.

Standard HFCWO Therapy (Control)

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.

Group Type: ACTIVE_COMPARATOR

The Vest® Model 105

Intervention Type: DEVICE

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.

Interventions

ELECTROVEST

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.

Intervention Type: DEVICE

The 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.

Intervention Type: DEVICE

Other Intervention Names

Electrostimulation Vibratory Vest; Standard HFCWO Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role: lead

Responsible Party

Rafael Rivilla Rivilla

Physiotherapist - Clinical Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

EXP - 00111621 / ITC-20181118

Identifier Type: -

Identifier Source: org_study_id