Daily lung insufflation training to help protect breathing in ALS
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
NA · National Center of Neurology and Psychiatry, Japan · NCT07257302
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Center of Neurology and Psychiatry, Japan (other) |
| Locations | 1 site (Kodaira, Tokyo) |
| Trial ID | NCT07257302 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kodaira, Tokyo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis, LIC Trainer, lung volume recruitment, respiratory rehabilitation, FVC, ALS, ALSFRS-R, cough peak flow