The TESLA MICRON study is investigating  whether ZeusOSA, a transcutaneous electrical nerve stimulation (TENS) medical device, may  help improve breathing during sleep in people formally diagnosed with obstructive sleep apnoea (OSA) who find it difficult to adhere to the continuous positive airway pressure (CPAP) treatment. 

The study will compare ZeusOSA with usual care (continued CPAP treatment) and assess how well the device works, how comfortable it is to use, and how regularlyn people use it. 

ZeusOSA is a nightly home-use transcutaneous electrical stimulation medical device designed to alleviate OSA symptoms and improve sleep-disordered breathing. The device is worn under the chin while you sleep with a single-use adhesive hydrogel pad that delivers gentle electrical stimulation through the skin.  

The stimulation is similar to that used in a TENS machine. It works by gently stimulating the hypoglossal nerve, which activates muscles in the throat, including the genioglossus muscle, that help keep the airway open while you sleep. These muscles can relax when you fall asleep, which may cause lead to snoring or pauses in breathing. Regular mild electrical pulses help prevent this relaxation 

The ZeusOSA device allows users to adjust the stimulation level themselves using the '+' and '−' buttons on the device. There are ten levels of intensity, and each person should select the level that feels most comfortable for them. The study team will guide how to adjust the device safely. If any discomfort occurs, participants should reduce the level or stop using the device and contact the study team for advice. 

OSA is the most common form of sleep-disordered breathing. It can cause poor sleep, excessive daytime sleepiness, and long-term health problems if left untreated. The gold standard treatment for OSA is CPAP, which is recommended in national guidelines. However, over 50% of patients discontinue use because they find CPAP difficult to use long-term due to discomfort when wearing the mask while sleep. 

When CPAP is not tolerated, treatment options are limited. Some people may benefit from lifestyle changes or dental devices, but these do not work for everyone and may not be suitable or available for all patients. Other treatments involving electrical stimulation of the airway muscles exist, but often require surgery and are not suitable for many people. 

This research is being carried out to explore whether a non-invasive, home-use medical device can offer an additional treatment option for people with OSA who are unable to tolerate CPAP.  

Taking part in this study may or may not provide a direct benefit to you. You may experience an improvement in your symptoms, but this cannot be guaranteed as the device is still being evaluated. Participants will receive close monitoring of their sleep and symptoms during the study, which some participants may find helpful.  

The information collected will also help doctors and researchers gain a better understanding of OSA and develop future treatments for people who find CPAP difficult to use. 

Following successful completion of the trial, all participants will be offered a free Zeus anti-snoring device as a thank-you gift. This is the wellness version of the device and is approved only for the alleviation of snoring related to the soft palate and tonsils. It is not intended for medical use in OSA and must not be used as a substitute for prescribed clinical treatment of OSA. 

Although there are no known serious disadvantages to participating in the study, possible disadvantages of participation include the time and effort required to attend clinic visits, complete questionnaires, and use study equipment at home. 

ZeusOSA medical device uses a single-use adhesive hydrogel pad to deliver mild electrical stimulation through the skin. For some people, this may cause a local skin reaction, such as rash, redness, itching, or discomfort. In most cases, any skin irritation is mild and short-lasting. 

You should report any persistent, worsening, or concerning symptoms to the study team as soon as possible. They may advise you to stop use of the device and, if necessary, arrange an assessment or provide further advice. 

Taking part in the study is completely voluntary. Whether or not you choose to take part, or if you decide to withdraw from the study at any time, this will not affect the standard of care you receive now or in the future. 

If you choose to withdraw, please speak to your consultant or speak/ email the study team atgstt.tesla-micron@nhs.netswer

Your information will be handled in confidence. You will be assigned a unique study identification number, and this will be used on study documents and results instead of your name (pseudonymisation). Only authorised members of the research team will be able to link your name to this study number.Your identity will ALWAYS remain anonymous.

Any harm you might suffer, or any side effects associated with theZeusOSAdevice,must be reported. Please inform your consultant or contact the trial study team atgstt.tesla-micron@nhs.net

If you think your ZeusOSA is not working, you may briefly test the device on your forearm to check that stimulation can be felt. Attach the pad to the device and place it on the inside of your forearm - this area is more sensitive to stimulation. Turn ZeusOSA ON and select a low setting to start. Gradually increase the setting until you can feel stimulation. If you can feel a gentle pulsing or tingling on any setting, the device is working correctly. 

If you can’t feel anything, please contact the study team at gstt.tesla-micron@nhs.net 

If you need additional hydrogel pads, please contact the study team at 

 gstt.tesla-micron@nhs.net 

If you have any concerns or want to complain about any part of your involvement in this study, you can talk to your consultant or research fellow. If you are not happy with the study and want to make a complaint, you can use the NHS complaints process – your hospital will tell you how. You can also talk to the independent Patient Advice and Liaison Service (PALS) at your hospital.  

If something goes wrong and you are harmed during the research, and this is due to someone’s negligence, you may have grounds for legal action for compensation against the study sponsor (Zeus Sleep Ltd), but you may have to pay your legal costs. The normal NHS complaints mechanism will still be available to you. 

If, during the study, you lose the capacity to make decisions for yourself, including providing consent, the study team will withdraw you from the study. No further research-related procedures, interventions, or study-specific data collection will take place. 

Any information already collected before your withdrawal may still be retained and used for the purposes of the study, in accordance with the study protocol and applicable data protection requirements. Your usual NHS care will continue and will not be affected by your withdrawal from the study.