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Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

NCT07257302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-09

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong survival in people with amyotrophic lateral sclerosis (ALS).

The main questions it aims to answer are:

* Does early and continuous LIC training slow the decline in forced vital capacity (FVC)?
* Does LIC training delay the need for tracheostomy or noninvasive ventilation (NIV)? This single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 15 adults with ALS, diagnosed according to the El Escorial or Awaji criteria.

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
* Have lung tests, including FVC, LIC, maximum insufflation capacity (MIC), cough peak flow (CPF), and complete the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) There is no control group within this trial; researchers will compare results with matched historical controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DEVICE

LIC 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.

Sponsors & Collaborators

  • National Center of Neurology and Psychiatry, Japan

    lead OTHER

Principal Investigators

  • Taiyo Kawaguchi, MD · National Center of Neurology and Psychiatry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-03-31
Completion
2030-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257302 on ClinicalTrials.gov