RecruitingNot ApplicableNCT07257302

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


Sponsor

National Center of Neurology and Psychiatry, Japan

Enrollment

25 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called LIC Trainer (Lung Insufflation Capacity Trainer) for people with amyotrophic lateral sclerosis(als). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELIC Trainer (Lung Insufflation Capacity Trainer)

The LIC Trainer is a medical device designed to enable lung insufflation through a one-way valve system, allowing passive air stacking without voluntary glottic closure. The device includes a safety valve that automatically releases pressure above 60 cmH₂O and a manual relief valve to ensure patient safety. It is used with a bag-valve-mask to deliver multiple assisted insufflations, approximately 10 per session, twice daily. Participants with amyotrophic lateral sclerosis (ALS) perform LIC training at home after initial instruction by physical therapists and are re-evaluated every 3 months for up to 36 months.


Locations(1)

National Center of Neurology and Psychiatry (NCNP)

Kodaira, Tokyo, Japan

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NCT07257302


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