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HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial

NCT07656714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-06-18

No results posted yet for this study

Summary

This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation.

Conditions

Interventions

DEVICE

High-frequency chest wall oscillation (HFCWO) vest

Chest wall oscillation vest delivering high-frequency vibrations to mobilise secretions, used in addition to mechanical cough assist device during the 3-month intervention period.

DEVICE

Mechanical cough assist

Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.

Sponsors & Collaborators

  • Hospital Universitario Virgen Macarena

    lead OTHER

Principal Investigators

  • Concepcion Romero Muñoz · Hospital Universitario Virgen Macarena

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-11-02
Completion
2025-04-27

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT07656714 on ClinicalTrials.gov