NCT07257302 Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis
| NCT ID | NCT07257302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Center of Neurology and Psychiatry, Japan |
| Condition | Amyotrophic Lateral Sclerosis (ALS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-11-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Taiyo Kawaguchi, MD
PRINCIPAL INVESTIGATOR
National Center of Neurology and Psychiatry
Frequently Asked Questions
Who can join the NCT07257302 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Amyotrophic Lateral Sclerosis (ALS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07257302 currently recruiting?
Yes, NCT07257302 is actively recruiting participants. Contact the research team at rinri-jimu@ncnp.go.jp for enrollment information.
Where is the NCT07257302 trial being conducted?
This trial is being conducted at Kodaira, Japan.
Who is sponsoring the NCT07257302 clinical trial?
NCT07257302 is sponsored by National Center of Neurology and Psychiatry, Japan. The principal investigator is Taiyo Kawaguchi, MD at National Center of Neurology and Psychiatry. The trial plans to enroll 15 participants.
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