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

NCT07175012 | Completed

• 1 other identifier: EXP - 00111621 / ITC-20181118
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Electrostimulation; High-Frequency Chest Wall Oscillation (HFCW; Airway Clearance; Chronic Respiratory Diseas; Respiratory Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Volume of Expectorated Sputum

  Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session

  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.

  Immediately after each intervention session

Secondary Outcomes (9)

• Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and 24-48 hours after each intervention.

• Maximal Inspiratory Pressure (PImax)

  Baseline and 24-48 hours after each intervention.

• Maximal Expiratory Pressure (PEmax)

  Baseline and 24-48 hours after each intervention.

• Six-Minute Walk Distance (6MWD)

  Baseline and 24-48 hours after each intervention.

• DLCO (Diffusing Capacity for Carbon Monoxide)

  Baseline and 24-48 hours after each intervention.

Study Arms (2)

ELECTROVEST Intervention

EXPERIMENTAL

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

Standard HFCWO Therapy (Control)

ACTIVE COMPARATOR

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

Interventions

ELECTROVEST 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.

Also known as: Electrostimulation Vibratory Vest

ELECTROVEST Intervention

The Vest® Model 105 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.

Also known as: Standard HFCWO Therapy

Standard HFCWO Therapy (Control)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Related Publications (1)

• Rivilla Rivilla R, Mendez Alonso AY, Roque Betancourt E, Vazquez Sanchez RM, Ortiz Molina I, Bonail Acuna B, Elena Perez MDM, Tejero Garcia S, Diaz Gutierrez F, Quintana Gallego E, Giraldez Sanchez MA, Cejudo Ramos P. Electrovest(R): A novel portable electro-vibratory device for airway clearance in chronic hypersecretory lung diseases. Pulmonology. 2025 Dec 31;31(1):2594888. doi: 10.1080/25310429.2025.2594888. Epub 2025 Dec 1.

  PMID: 41324124 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist - Clinical Researcher

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: September 16, 2025
• Study Start: October 2, 2023
• Primary Completion: March 7, 2025
• Study Completion: May 20, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-07

Locations

ES (1)