Zeus Sleep technology: A UK-based multi-centre randomised controlled trial using transcutaneous electrical stimulation (TESLA) in patients with obstructive sleep apnoea (TESLA MICRON UK)
A small electrical device worn on the chin during sleep could offer a non-invasive alternative to the standard breathing mask that more than half of patients abandon within a year. Obstructive sleep apnoea causes repeated airway collapse during sleep, leading to poor sleep quality and oxygen drops. The current gold-standard treatment, a mask that delivers continuous air pressure, is often abandoned because of discomfort. For those who cannot tolerate it, the NHS typically offers only lifestyle advice, which is frequently insufficient. A surgically implanted nerve stimulator exists but is highly invasive and expensive. This trial tests a device called ZeusOSA, which stimulates the hypoglossal nerve through the skin rather than through surgery. If it proves effective, it could give the NHS a middle-ground option that is far less invasive than an implant yet more effective than lifestyle advice alone. Success could reduce the long-term health risks and costs associated with untreated sleep apnoea, while offering patients a practical, comfortable treatment they will actually use.
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Research Question: Can ZeusOSA provide a more effective alternative for NHS patients compared to standard care for non-CPAP-compliant individuals, with mild to moderate OSA, by improving adherence, usability, and clinical outcomes? Background: Obstructive Sleep Apnoea (OSA) is a prevalent but underdiagnosed condition affecting over 8 million people in the UK and 1 billion globally. It occurs when airflow is repeatedly reduced or stopped during sleep, leading to poor sleep quality and oxygen drops. Severity is measured using the Apnoea-Hypopnoea Index (AHI): Mild: AHI 5–14 events/hour (with symptoms) Moderate: AHI 15–29 events/hour Severe: AHI ≥30 events/hour While Continuous Positive Airway Pressure (CPAP) is the gold-standard treatment, over 50% of patients discontinue use within a year due to discomfort. Non-adherence increases symptom burden, long-term health risks, and NHS costs. Hypoglossal nerve stimulation (HNS) has been proven to improve OSA symptoms but to date HNS has only been available through surgically implanted devices which are expensive (£30K–£65K) and very invasive, Current NHS care for non-CPAP-compliant patients mainly relies on lifestyle advice, which is often insufficient. ZeusOSA is a non-invasive HNS alternative to the implanted device, using transcutaneous electrical stimulation (TESLA) to activate the hypoglossal nerve externally. By much improved comfort and ease of use, ZeusOSA has the potential to boost adherence, improve outcomes, and reduce costs. Aims and Objectives: This study evaluates whether ZeusOSA is a superior treatment for non-CPAP-compliant patients by assessing adherence, patient experience, and clinical effectiveness. The detailed work plan (also see Research Plan (3.1)): Evaluate Clinical Effectiveness and Safety (WP5, supported by WP1, WP2, WP4) •Conduct a randomised controlled trial (RCT) using the TRL10 ZeusOSA device through NHS sleep centres. • Ensure diverse recruitment with Hope2Sleep overseeing EDI (WP3). • Primary Outcome: Demonstrate a statistically significant difference in AHI between the ZeusOSA group and the standard non-CPAP lifestyle management group. • Secondary Outcomes: o Adherence (measured via electronic monitoring and patient self-reporting). o Improved sleep quality and daily function (PSQI, ESS). o Patient-reported usability and satisfaction (qualitative feedback). o NHS cost-effectiveness modelling (healthcare resource use, QALYs). Assess Long-Term Adherence and Usability (WP5, WP6, WP8) Monitor adherence electronically; gather patient experience via surveys/interviews. Analyse adherence-outcome links (WP8). Measure Patient-Reported Outcomes & Quality of Life (WP5, WP8): Use validated tools (e.g., PSQI, ESS, EQ-5D) and qualitative feedback. Cost-Effectiveness Analysis (WP6): Compare ZeusOSA costs to NHS savings and productivity gains. Regulatory Compliance (WP1, with WP7 and WP10): Secure approvals (MHRA, IRAS), ensure compliance (GCP, GDPR), and complete governance processes by Month 9. Methods: 186 adults with mild-to-moderate OSA, non-adherent to CPAP, will be randomised (1:1) to ZeusOSA or standard care. See Appendix 7 for PICOTT and sample size detail. Timelines Months 1–12: Approvals, site setup, training Months 13–30: Recruitment and trial execution Months 31–36: Analysis, health economics, dissemination, NICE submission Anticipated Impact and Dissemination: ZeusOSA could improve adherence, reduce NHS costs, and enhance patient outcomes. Findings will be shared via peer-reviewed journals, conferences, and with NHS policymakers and patient groups to support national adoption.
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