NCT07656714Completed
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 16 Jun 2026
- Start date
- 15 Apr 2021
- Primary completion date
- 2 Nov 2023
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07656714
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 15 Apr 2021 to the primary completion date, 2 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment
- Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma
Other
- Need for invasive mechanical ventilation
- Total dependence on non-invasive ventilation (NIV)
- Severe bulbar involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.