A new clinical trial sponsored by Efforia, Inc. is investigating the potential of the WAVWatch 2.0 device to alleviate stress. With recruitment now open, this study offers new insights into the application of medical devices in stress management. Key stakeholders in clinical, quality, and regulatory fields should pay attention to its progress.
What changed?
The study titled “Sound Stops Stress Study: Evaluating the WAVWatch Effect” has entered the recruitment phase. Conducted under the sponsorship of Efforia, Inc., this trial aims to explore whether the WAVWatch 2.0, a wearable medical device, can significantly reduce stress levels in participants. Its findings could potentially expand applications of device-based interventions for stress management.
About the WAVWatch 2.0
The WAVWatch 2.0 is a wearable device designed to use sound wave technology to manage stress. According to manufacturer data, the device delivers targeted sound frequencies that claim to promote relaxation and well-being. The trial represents an opportunity to establish clinical evidence for its effectiveness, performance, and intended purpose under real-world conditions.
Study goals
The primary objective of the trial is to assess the effectiveness of WAVWatch 2.0 in reducing stress among participants. Secondary objectives include evaluating the safety profile of the device and understanding how well it performs in daily usage. These evaluations align with efforts to ensure compliance with medical device regulations such as MDR Annex XIV, requiring rigorous evidence of performance, safety, and benefit-risk balance.
Efforia, Inc. has structured the trial to adhere to stringent clinical research protocols, ensuring data reliability and alignment with regulatory standards. The outcomes will provide guidance on potential regulatory submissions and future market applications for this class of device.
Why is this trial important?
Stress remains a growing global health concern with impacts on physical and mental health. Non-invasive solutions such as WAVWatch 2.0 could offer safer alternatives to pharmacological treatments if proven effective. Furthermore, this trial could drive further research into sound wave therapies in adjacent therapeutic areas.
FAQ
1. Who is sponsoring this trial?
Efforia, Inc. is the sponsor, leading the design and implementation of the study.
2. Who can participate?
The inclusion and exclusion criteria will determine participant eligibility. Interested individuals can visit the recruitment link for more details.
3. How does the WAVWatch 2.0 function?
It utilizes sound wave technology, delivering specific frequencies aimed at stress reduction.
4. How can I learn more?
Additional information on the study is available through the official link provided below.
Conclusion
Efforia, Inc.’s clinical trial for the WAVWatch 2.0 marks a significant step in exploring device-based stress management solutions. As recruitment is currently open, this study could yield critical findings beneficial for regulatory paths and therapeutic advancements. Stakeholders are encouraged to monitor developments closely.
Disclaimer
This article is intended for informational purposes only, intended for professionals in clinical, quality, and regulatory fields. It does not constitute legal or regulatory advice. Always refer to official guidelines for specific compliance requirements.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07281989?term=medical+device