Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

Recruiting now · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

The goal of this clinical trial is to determine whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong tracheostomy-free survival in people with amyotrophic lateral sclerosis (ALS). The main questions are: Does early and continuous LIC training slow the decline in forced vital capacity (FVC)? Does LIC training prolong the time to tracheostomy or death? This single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 25 adults with ALS diagnosed according to the El Escorial or Awaji criteria. This is a single-arm study with no concurrently enrolled control group. Comparative analyses will use matched external controls. PRO-ACT will be used primarily to evaluate short-term respiratory-function trajectories, while JACALS, if data access is approved, will be used primarily to evaluate long-term time-to-event outcomes. Participants will: * Use the LIC Trainer device to perform lung insufflation training twice daily at home * Visit the clinic every 3 months for respiratory and functional assessments * Undergo respiratory tests, including FVC, LIC, maximum insufflation capacity (MIC), and cough peak flow (CPF) * Complete the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

Key facts

Study ID

NCT07257302

Run by

National Center of Neurology and Psychiatry, Japan

People needed

25

Starts

2025-11-01

Expected to finish

2030-03-31

Last updated by the study team

2026-07-30

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20 years or older
• Diagnosis of amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria
• Not using noninvasive ventilation (NIV) and without tracheostomy at the start of LIC training
• Able to perform study assessments and provide written informed consent (or assisted signature with communication aid)

You may not qualify if…

• Chronic pulmonary disease other than ALS (e.g., COPD, interstitial lung disease)
• Severe cognitive or communication impairment preventing study participation
• Uncontrolled cardiovascular disease, including unstable angina, recent myocardial infarction, decompensated heart failure, serious arrhythmia, severe aortic stenosis, or active myocarditis/endocarditis
• Uncontrolled hypertension
• Acute systemic illness or fever
• Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension
• Severe hepatic or renal dysfunction
• Any condition judged inappropriate by the investigator

Where it is running

• National Center of Neurology and Psychiatry (NCNP) — Kodaira, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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