Spinal Muscular Atrophy Randomized Controlled Trial on Cough Techniques (Patient tailored airway clearance in patients with Spinal Muscular Atrophy: a randomized controlled trial comparing air stacking and mechanical insufflation-exsufflation.)

Spinal Muscular Atrophy Randomized Controlled Trial on Cough Techniques (Patient tailored airway clearance in patients with Spinal Muscular Atrophy: a randomized controlled trial comparing air stacking and mechanical insufflation-exsufflation.) - SMARCT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56529

Enrollment

Registered

2024-02-06

Start date

2024-07-09

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal muscular atrophy (SMA)

Interventions

MI-E or AS with MAC should be used at least twice a day

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients with Spinal Muscular Atrophy Peak expiratory cough flow = 10 years or PECF

Exclusion criteria

Exclusion criteria: - Severe gastroesophageal reflux with risk of aspiration despite treatment - Severe esophageal and gastric varices - Recent pneumothorax (

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the immediate effect on improvement of Peak Expiratory Cough Flow (PECF) over a period of 3 years	—

Secondary

Measure	Time frame
Secondary endpoints are the number of respiratory tract infections (RTIs) requiring hospital admissions or antibiotics, patient reported patient satisfaction, lung function decline, patient satisfaction, adverse events and compliance to treatment	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)