Daily lung insufflation training to help protect breathing in ALS
Official title: 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
Run by National Center of Neurology and Psychiatry, Japan · NCT07257302 · Data updated 2026-11-12
This project will test whether using a home LIC Trainer twice daily can slow breathing decline and delay the need for ventilatory support in people with ALS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | National Center of Neurology and Psychiatry, Japan Academic / other |
| Locations | 1 site (Kodaira, Tokyo) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | March 31, 2030 |
| Study ends | March 31, 2030 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07257302 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 or older with ALS (El Escorial or Awaji criteria) who are not using NIV or tracheostomy and who can perform the device training and clinic visits are ideal candidates.
✕Probably not a fit
People already on NIV or with a tracheostomy, those with other chronic pulmonary diseases, or those with severe cognitive or medical instability are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center study at the National Center of Neurology and Psychiatry in Japan will enroll 15 adults with ALS who are not yet on noninvasive ventilation or tracheostomy. Participants will perform lung insufflation capacity (LIC) training with a licensed LIC Trainer device at home twice daily and return to the clinic every three months for respiratory and functional assessments. Key outcomes include forced vital capacity (FVC), maximum insufflation capacity (MIC), cough peak flow (CPF), and ALSFRS-R scores, with monitoring for time to NIV or tracheostomy and survival. The protocol uses device-assisted air stacking to enable passive insufflation even in patients with impaired glottic control.
Why it matters
Potential benefit: If successful, LIC training could help people with ALS keep lung volumes higher for longer and delay the need for ventilation or tracheostomy.
How similar studies have gone: Manual lung volume recruitment has shown some benefit in small studies, but the device-based LIC Trainer approach is relatively new and has limited trial evidence to date.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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National Center of Neurology and Psychiatry (NCNP)
Kodaira, Tokyo, Japan Recruiting
Study contacts
- Principal investigator: Taiyo Kawaguchi, MD — National Center of Neurology and Psychiatry
- Study coordinator: Study Office
- Email: rinri-jimu@ncnp.go.jp
- Phone: +81-42-341-2712
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.