Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT07257302

Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

Led by National Center of Neurology and Psychiatry, Japan · Updated on 2025-12-09

15

Participants Needed

1

Research Sites

230 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Diagnosed with 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Center of Neurology and Psychiatry (NCNP)

Kodaira, Tokyo, Japan, 187-8551

Actively Recruiting

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Research Team

S

Study Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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