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Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

RecruitingNA

Sponsor: National Center of Neurology and Psychiatry, Japan

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Interventions: LIC Trainer (Lung Insufflation Capacity Trainer)

Countries: Japan

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)

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Locations (1)

Kodaira, Tokyo, Japan