Published February 15, 2026, this regulatory update covers a Florida State University trial testing high intensity inspiratory muscle training for obesity related cerebrovascular function and immune cell activity.
The article explains what has changed in the study design and what this may mean for device makers clinicians and regulators. The trial studies two intensity levels of an inspiratory muscle training device and is focused on obesity cerebrovascular function and immune cell activity. Florida State University is listed as sponsor and coordinating center for recruitment and oversight.
What changed in this regulatory update?
The trial tests a device based approach to inspiratory muscle training with two intensity levels. The high intensity device is designed to stress inspiratory muscles to a greater degree than a low intensity option. The study targets individuals with obesity and examines potential effects on cerebrovascular function as well as immune cell activity. Florida State University serves as sponsor and coordinating site for recruitment and oversight.
What is the study setup?
Interventions include high intensity inspiratory muscle strength training and a low intensity comparable device. Subjects are enrolled under a protocol that aligns with clinical trial standards for device evaluation and safety monitoring. The trial is listed as recruiting on ClinicalTrials.gov.
How does this fit regulatory expectations for respiratory muscle training devices?
Regulatory language for devices of this type emphasizes intended use performance measures and safety. The sponsor statements are from an academic institution and reflect MDR oriented assessment for device based approaches to non pharmacologic conditioning. The information provided is intended to support regulatory discussions and does not constitute a claim of effectiveness.
What are the study details?
Sponsored by Florida State University the trial evaluates two intensity levels for inspiratory muscle training devices in adults with obesity. Outcome measures are not yet reported here. The ClinicalTrials.gov record is accessible at ClinicalTrials.gov NCT07406295.
What does this mean for patients and regulators?
If results show safety and feasibility for high intensity inspiratory muscle training in the populations described device makers may consider further studies and regulatory submissions for similar devices. Regulators will look for clear intended use statements robust risk management and appropriate post market surveillance concepts related to this non pharmacologic option.
FAQ
- 1. What is being tested in this trial? The trial tests two intensity levels of inspiratory muscle training devices in adults with obesity focusing on cerebrovascular function and immune cell activity.
- 2. Who is sponsoring and coordinating the research? Florida State University represents the sponsor and coordinating center for recruitment and oversight.
- 3. Which conditions are being studied? The trial targets obesity, cerebrovascular function and immune cell activity.
- 4. What devices are used in the trial? A high intensity inspiratory muscle training device and a low intensity comparable device are evaluated.
- 5. Where can I find the trial record for more information? The record is available at ClinicalTrials.gov with the link above.
Conclusion
The trial described reflects an academic led effort to assess non pharmacologic respiratory training in obesity and cerebrovascular health with immune endpoints. Regulators will await results to determine if further clinical evaluation and device level submissions are warranted.
Disclaimer
This information is for professional regulatory use only. It is not legal advice and does not replace official guidance.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07406295?term=medical+device