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Completed
NCT07656714
HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial
Conditions: Amyotrophic Lateral Sclerosis, Respiratory Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 14
Sponsor: Hospital Universitario Virgen Macarena
Location: Hospital Universitario Virgen Macarena Seville Andalusia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07656714). StuddyBuddy aggregates publicly available trial information.