Publication Date: December 2, 2025
A newly announced clinical study focuses on innovating respiratory care for individuals with Amyotrophic Lateral Sclerosis (ALS). Sponsored by the National Center of Neurology and Psychiatry, Japan, the study investigates the use of the Lung Insufflation Capacity (LIC) Trainer, a device aimed at assisting respiratory capacity improvement. Healthcare professionals, clinical researchers, and regulatory teams involved in ALS care should take note of this prospective research initiative.
In this article:
- What changed?
- What are the study objectives?
- Why is this significant?
- FAQ
- Conclusion
- Disclaimer
- Announcement details
What changed?
The study is actively recruiting participants to establish whether the LIC Trainer can reliably enhance lung insufflation capacity in ALS patients. Given the progressive respiratory decline experienced in ALS, such focused interventions could be pivotal in delaying respiratory complications while improving quality of life. The study aims to collect data systematically to evaluate the device’s performance and role within broader respiratory management protocols.
What are the study objectives?
What is the LIC Trainer?
The LIC Trainer is a medical device specifically designed to assist patients in increasing their lung insufflation capacity through targeted training. By helping users practice controlled breathing techniques, the device intends to complement traditional respiratory therapies.
Key Research Targets
- Evaluate the effectiveness of the LIC Trainer in improving respiratory function for ALS patients.
- Analyze patient safety and device usability through structured methodologies.
- Identify measurable changes in lung insufflation parameters over the study duration.
The findings aim to inform future strategy on respiratory care innovations in ALS management.
Why is this significant?
Advances in respiratory care for ALS patients are crucial to mitigating the disease’s impact on breathing and extending quality-assisted survival time. Devices like the LIC Trainer represent promising options for improving clinical outcomes. Observations from this study may also influence future recommendations for medical device integration in ALS care.
For regulatory agencies, the study outlines a clear commitment to safety, data transparency, and alignment with evidence-based evaluations. This builds confidence for eventual approvals or further clinical trials targeting similar device designs.
FAQ
1. Who is eligible to participate?
The study is recruiting individuals diagnosed with ALS who meet specific inclusion criteria outlined by the research team.
2. What is lung insufflation capacity?
Lung insufflation capacity refers to the maximum volume of air a person can draw into their lungs. This measurement is critical for patients with compromised respiratory functions.
3. Where can I find additional details?
More information can be reviewed directly at the clinical trial’s record hosted on ClinicalTrials.gov.
Conclusion
This prospective study aims to address a vital need in ALS care, focusing on enhancing patient outcomes through targeted respiratory interventions. Clinical and regulatory teams monitoring innovations in medical devices for chronic disease management should follow the evolution of this trial closely.
Disclaimer
This content is for informational purposes. It is not legal advice or a substitute for professional regulatory guidance. Always consult appropriate experts or official resources for compliance decisions.
Announcement details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07257302?term=medical+device