Lung Insufflation Training Device for Breathing Function in Amyotrophic Lateral Sclerosis
Tests a home lung training device to help keep breathing function in adults with ALS.
Plain-language title generated from the registry record
Registry title: Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis
Key facts
- Where
- Kodaira, JapanSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ALS who do not yet use noninvasive ventilation and have no tracheostomy. They train their lungs with the LIC Trainer device at home twice a day.
- Age
- 20 years or older
- Sex
- All sexes can join.
- Disease stage
- ALS diagnosed by the El Escorial or Awaji criteria; not using noninvasive ventilation (NIV) and no tracheostomy at the start of LIC training.
- Earlier treatment
- Must not be using noninvasive ventilation (NIV) and must not have a tracheostomy at the start of training.
Main reasons for not taking part
- Chronic lung disease other than ALS, such as COPD or interstitial lung disease
- Severe problems with thinking or communication that prevent taking part
- Uncontrolled heart or blood vessel disease, or uncontrolled high blood pressure
- Acute illness or fever
- Severe liver or kidney problems
Read by machine on 12 November 2026.
Where in Japan
- National Center of Neurology and Psychiatry (NCNP)Kodaira, JapanContact: Study OfficeTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National Center of Neurology and Psychiatry, Japan
- Trial code
- NCT07257302
- Record updated
- 30 July 2026
- Original description
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).Read full original descriptionShow less
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
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)
Inclusion: 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: 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; Severe hepatic or renal dysfunction.