TESLA-MICRON, version 1
Research type
Research Study
Full title
Zeus Sleep Technology: A UK-based multi-centre randomised controlled trial using transcutaneous electrical stimulation in patients with obstructive sleep apnoea (TESLA)
IRAS ID
356707
Contact name
Joerg Steier
Contact email
Sponsor organisation
Zeus Sleep Limited
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
This research aims to determine the effectiveness of a new non-invasive medical device named ZeusOSA as a treatment option for NHS patients suffering from mild-to-moderate Obstructive Sleep Apnoea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP) machines. The study will evaluate whether ZeusOSA enhances adherence (the consistency of device use), comfort, sleep quality, and overall health outcomes when compared to standard NHS care.
OSA is a prevalent condition affecting an estimated 8 million individuals in the UK. It causes interrupted breathing during sleep, leading to various health issues, including poor mental well-being, increased risk of car accidents, heart disease, and stroke. Currently, CPAP machines are the primary treatment, but over half of the patients discontinue use within a year due to discomfort.
Alternative treatments, such as surgical options, are often too costly and invasive, leaving many patients reliant on basic lifestyle change, which may not alleviate their symptoms. ZeusOSA is a compact device placed under the chin that delivers mild electrical pulses to stimulate a nerve, helping keep the airway open during sleep. This approach is non-invasive and more user-friendly, offering a potentially more cost-effective solution for the NHS.
The study will involve 186 adult participants diagnosed with mild-to-moderate OSA who cannot tolerate CPAP. Participants will be randomly assigned to receive either ZeusOSA or standard lifestyle care over an 18-month period across 7 NHS sleep centres. Data on sleep quality and daily functioning will be collected through questionnaires and device monitoring, with statistical analysis conducted by experts. The patient charity Hope2Sleep has played a vital role in shaping the study, ensuring that patient perspectives are reflected throughout. Results will be disseminated through journals, conferences, and shared with NHS stakeholders to advocate for NHS adoption if the device is proven effective.REC name
West of Scotland REC 4
REC reference
26/WS/0082
Date of REC Opinion
23 Jun 2026
REC opinion
Further Information Favourable Opinion