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

NCT07175012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    collaborator OTHER

  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2025-03-07
Completion
2025-05-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175012 on ClinicalTrials.gov