A new clinical trial focusing on an innovative device for obstructive sleep apnoea (OSA) has been announced. The study will compare the ZeusOSA device with the established CPAP treatment. Sponsored by Zeus Sleep Ltd and partnered with several prominent healthcare and academic institutions across the UK, the trial is currently not recruiting participants.
In this article:
What is the ZeusOSA device?
The ZeusOSA device uses transcutaneous electrical stimulation (TES) technology to address obstructive sleep apnoea, a common condition that disrupts breathing during sleep. Unlike CPAP (continuous positive airway pressure), which uses air pressure to keep airways open, ZeusOSA applies mild electrical impulses externally to facilitate unobstructed breathing. Its non-invasive design aims to improve patient compliance and comfort, addressing some known challenges with CPAP adherence.
Obstructive sleep apnoea affects many individuals globally, often leading to poor sleep quality and related health risks like cardiovascular disease. Devices like ZeusOSA represent an important effort to address treatment barriers.
Who is involved?
The trial is headed by Zeus Sleep Ltd in collaboration with a range of healthcare and academic organizations, including Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, and the Royal Brompton & Harefield NHS Foundation Trust. Additional contributors include other NHS Trusts and leading institutions like Imperial College Healthcare NHS Trust and the Royal Papworth Hospital. Together, they bring extensive expertise in respiratory medicine and clinical trials.
Partnerships with this calibre of institutions demonstrate the effort to ensure scientific rigor and patient safety. These collaborators highlight the strong interest in advancing treatment options for obstructive sleep apnoea.
What comes next?
The trial is currently listed as “not yet recruiting.” Regulatory compliance and detailed review stages will likely precede participant enrollment. Early-stage regulatory oversight ensures that all patient safety and device performance parameters meet the standards required for clinical trials.
Clinical trials such as this follow a phased approach, starting with smaller cohorts to assess safety and performance and often expanding to larger groups. Data collected will compare effectiveness, safety, and patient adherence between ZeusOSA and the established CPAP devices.
Updates on recruitment and study outcomes will be monitored closely by stakeholders in sleep medicine. Professionals involved in regulatory affairs and clinical research will be particularly interested in the findings, which may mark an advancement in OSA treatment protocols.
FAQ
- What is the primary goal of this trial?
The trial aims to evaluate the safety, efficacy, and patient adherence of the ZeusOSA device compared to CPAP for treating obstructive sleep apnoea. - When will recruitment begin?
The trial is currently marked as “not yet recruiting.” Updates will depend on site readiness and regulatory completion. - Who sponsors this trial?
Zeus Sleep Ltd serves as the primary sponsor in collaboration with leading NHS Trusts and renowned academic institutions.
Conclusion
This trial signals an important exploration of alternative treatments for obstructive sleep apnoea. Clinical teams, regulatory professionals, and healthcare providers should monitor developments closely. Devices like ZeusOSA may offer a less invasive solution to improve patient outcomes and adherence compared to traditional methods.
Disclaimer
This announcement is for informational purposes only and does not serve as legal or regulatory advice. For specific guidance, consult your regulatory or legal advisors.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07343362?term=medical+device