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

Effect of High-frequency Chest Wall Oscillation (HFCWO) Via Chest Vest Combined With Mechanical Cough Assist Versus Mechanical Cough Assist Alone on Respiratory Infections and Hospital Admissions in Patients With Amyotrophic Lateral Sclerosis Receiving Non-invasive Ventilation: a Randomised Single-blind Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Respiratory Infection
• Intervention / Treatment: Device: High-frequency chest wall oscillation (HFCWO) vest; Device: Mechanical cough assist

Detailed Description

Patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation (NIV) at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena (Seville, Spain) were randomised to two parallel groups. The experimental group received high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II/CC20) combined with mechanical cough assist, while the control group received mechanical cough assist alone. The intervention period lasted 3 months, followed by 3 months of follow-up. Primary outcomes included respiratory infections and hospital admissions. Secondary outcomes included respiratory function, quality of life, sleep quality, and secretion clearance capacity. The study was approved by the Ethics Committee of Hospital Universitario Virgen Macarena - Virgen del Rocío (code 2020-01) and sponsored by FISEVI (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalusia
    • Seville, Andalusia, Spain, 41009
      • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm label Experimental: HFCWO plus mechanical cough assist; 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; 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.; Other Names: ComfortCough II , CC20; Device: Mechanical cough assist; Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.; Other Names: Cough assist device
Active Comparator: Control: Mechanical cough assist alone; Patients received mechanical cough assist alone for 3 months followed by 3 months follow-up.	Device: Mechanical cough assist; Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.; Other Names: Cough assist device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital admissions	Number of hospital admissions due to respiratory causes during the study period	6 months (3 months intervention plus 3 months follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	Change in forced vital capacity percentage from baseline	6 months
Peak Cough Flow (PCF)	Change in peak cough flow from baseline	6 months
Gait analysis	Change in gait parameters assessed by GAITRite electronic walkway system and correlation with respiratory function (FVC)	6 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen Macarena
• Investigators: Principal Investigator: Concepcion Romero Muñoz, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): April 27, 2025

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis High-frequency chest wall oscillation Mechanical cough assist Respiratory infections Secretion clearance ALS
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Infections; Respiratory Tract Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis; Respiratory Tract Infections; Therapeutics; Respiratory Therapy; Chest Wall Oscillation
• Other Study ID Numbers: Tosedores 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No