NCT07257302Recruiting
Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis
Exploratory Study on the Effects of Lung Insufflation Capacity Training Using the LIC Trainer in Patients With Amyotrophic Lateral Sclerosis: A Single-Center Prospective Interventional Study
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- Nov 2025
- Primary completion date
- Mar 2030
- Lead sponsor
- National Center of Neurology and Psychiatry, Japan
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07257302
What you commit to
- Study type: Interventional
- Planned participants: 25
- From Nov 2025 to the primary completion date, Mar 2030
- 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
- 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
- Any condition judged inappropriate by the investigator
Other
- Severe hepatic or renal dysfunction
Who the study is looking for
- 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)
Age in the registry: 20 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 |
|---|---|---|---|
| National Center of Neurology and Psychiatry (NCNP) Coordinator of this site? Confirm its status | Kodaira | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.