Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis (NCT07257302) | Clinical Trial Compass
RecruitingNot Applicable
Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis
Japan25 participantsStarted 2025-11-01
Plain-language 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)
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival (time to tracheostomy or death)
Timeframe: From the start of LIC training (Day 0) until tracheostomy or death, up to 36 months
Trial details
NCT IDNCT07257302
SponsorNational Center of Neurology and Psychiatry, Japan