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

NCT07656714 | Completed

• 1 other identifier: Tosedores 1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Amyotrophic Lateral Sclerosis; Respiratory Infection

Keywords

Amyotrophic Lateral Sclerosis High-frequency chest wall oscillation Mechanical cough assist Respiratory infections Secretion clearance ALS

Outcome Measures

Primary Outcomes (1)

• Number of respiratory infections

  Number of respiratory infections requiring antibiotic treatment during the study period

  6 months (3 months intervention plus 3 months follow-up)

Secondary Outcomes (1)

• Number of hospital admissions

  6 months (3 months intervention plus 3 months follow-up)

Other Outcomes (3)

• Forced Vital Capacity (FVC)

  6 months

• Peak Cough Flow (PCF)

  6 months

• Gait analysis

  6 months

Study Arms (2)

arm label Experimental: HFCWO plus mechanical cough assist

EXPERIMENTAL

Patients received high-frequency chest wall oscillation via chest vest (ComfortCough II) combined with mechanical cough assist for 3 months followed by 3 months follow-up.

Device: High-frequency chest wall oscillation (HFCWO) vest; Device: Mechanical cough assist

Control: Mechanical cough assist alone

ACTIVE COMPARATOR

Patients received mechanical cough assist alone for 3 months followed by 3 months follow-up.

Device: Mechanical cough assist

Interventions

High-frequency chest wall oscillation (HFCWO) vest DEVICE

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.

Also known as: ComfortCough II , CC20

arm label Experimental: HFCWO plus mechanical cough assist

Mechanical cough assist DEVICE

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

Also known as: Cough assist device

Control: Mechanical cough assist alone; arm label Experimental: HFCWO plus mechanical cough assist

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of ALS according to the Revised El Escorial criteria
• Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena
• Age between 18 and 90 years
• Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted
• Ability to travel to the Neurolab centre

You may not qualify if:

• Need for invasive mechanical ventilation
• Total dependence on non-invasive ventilation (NIV)
• Severe bulbar involvement
• Cognitive impairment
• Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, Andalusia, 41009, Spain

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Respiratory Tract Infections

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Concepcion Romero Muñoz

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators assessing outcomes were blinded to treatment allocation. Blinding of participants and care providers was not feasible due to the nature of the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arms: experimental group receiving HFCWO chest vest combined with mechanical cough assist versus control group receiving mechanical cough assist alone. Randomised single-blind design.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 18, 2026
• Study Start: April 15, 2021
• Primary Completion: November 2, 2023
• Study Completion: April 27, 2025
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)