A new clinical trial focused on a resistance breathing device for stress management is set to begin. While recruitment has not yet started, the study is backed by Livotion, LLC, Purdue University, and the National Center for Complementary and Integrative Health (NCCIH). This development is relevant to clinical, quality, and regulatory professionals monitoring medical device innovations or research-driven therapies.
What changed?
The listed trial, titled “Real World Assessment of Resistance Breathing Device,” has yet to commence participant recruitment as of 2025-10-05. Key details highlight the involvement of multiple sponsors and institutions, showcasing collaboration in medical device evaluation. The study covers topics such as stress, breathing exercises, and stress management — a rapidly growing area in both medical and consumer device markets.
What are the details of the study?
The trial is hosted on ClinicalTrials.gov under the identifier NCT07187349. Livotion, LLC, appears as the device manufacturer and a primary sponsor. Additional sponsorship comes from Purdue University and NCCIH, highlighting academic and governmental interest in physiological-based stress relief therapies.
Although recruitment has not yet started, the study focuses on assessing the effectiveness of a resistance breathing device in real-world applications. Devices like this aim to improve stress management via controlled breathing techniques, showing potential for non-invasive and drug-free therapeutic benefit.
What is the expected impact?
This trial aims to provide evidence supporting the role of breathing-focused devices in stress management, a critical area given increasing rates of stress-related disorders. From a regulatory perspective, findings could also influence market pathways and point toward expanded device claims based on new clinical data.
The involvement of NCCIH and Purdue University underscores potential implications for research-backed interventions aligning with integrative health strategies. Livotion, LLC’s participation could further pave the way for their device’s validation, streamlining approvals or commercialization opportunities.
FAQ
1. Why is this study important?
This study could offer clinical data on the efficacy of resistance breathing devices for managing stress, addressing a growing need for non-drug therapies that complement existing techniques.
2. Who is sponsoring the study?
Livotion, LLC, Purdue University, and the National Center for Complementary and Integrative Health are coordinating the trial as key sponsors.
3. When does recruitment begin?
As of October 2025, recruitment has not yet started. Further updates may appear on ClinicalTrials.gov.
4. What is the device’s intended use?
The resistance breathing device is designed to support stress management through controlled breathing exercises.
Conclusion
Professionals working in clinical and regulatory fields should monitor this upcoming trial for important insights about stress management devices. Updates will likely provide data on safety, performance, and effectiveness, potentially impacting regulatory pathways for similar innovations.
Disclaimer
This content is for informational purposes only and does not constitute legal or professional advice concerning medical device regulation or clinical trial processes.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07187349?term=medical+device