An interventional study of ZeusOSA and CPAP in Obstructive Sleep Apnea, sponsored by Zeus Sleep Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Zeus Sleep Ltd · Not applicable, Interventional, and Treatment
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The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (CPAP) therapy over a period of 3-months in the community and compare results against usual care (ongoing CPAP therapy), evaluate acceptability, comfort and adverse events, and record outcomes for provision of the health economics analysis. The proposed study will provide us with data about the efficacy of the domiciliary use of the intervention from a UK-based prospective, multi-centre and randomised controlled trial (Phase III). We will understand whether the primary outcome parameter, the apnoea hypopnea index (AHI), or the secondary outcomes (e.g. 4% oxygen desaturation index (ODI), the Epworth Sleepiness Scale (ESS), compliance and comfort, Functional Outcome of Sleep Questionnaires (FOSQ), European Quality of Life Questionnaire (EQ-5D)) are suitable measures to assess control of OSA using TESLA within reasonable acceptance for the patients to provide the analysis of healthcare resource usage for assessment of cost-efficacy and quality-adjusted life years (QALYs). Responder analysis will provide insights into gender, socio-economic background and endotypes to predict who most suitably benefits from this treatment.
The TESLA-MICRON study is a UK-based, prospective, multi-centre, randomised controlled trial designed to evaluate the use of an investigational medical device, ZeusOSA, for the treatment of obstructive sleep apnoea in adults with poor adherence to continuous positive airway pressure (CPAP) therapy.
ZeusOSA uses gentle stimulation through the skin similar to that of a TENS machine. The device features a U-shaped lightweight silicone pad with a disposable adhesive hydrogel electrode pad (single-use) that delivers mild transcutaneous electrical nerve stimulation (TENS) to activate the hypoglossal nerve, thereby stimulating muscles to contract, particularly those associated with opening the airways (e.g., genioglossus muscle). Application of regular electrical pulses to these muscles help to maintain an open airway. The upper airway muscles might otherwise relax with sleep onset and cause vibrations and collapse in the throat whilst breathing, manifesting as snoring or sleep apnoea's or hypopneas. The stimulation level is customisable from level 1 (milder stimulation) to level 10 (stronger stimulation).
186 participants will be recruited with a prior diagnosis of obstructive sleep apnoea and low CPAP adherence at follow up (less than 4 hours/night) will be randomly assigned in a 1:1 ratio to either the intervention group or a usual care group. Recruitment will focus on a balanced ratio of men and women, as women are typically under-represented in studies of OSA and, due to a slim neck / collar size in comparison to men, likely to be responders to the TESLA treatment. Participants allocated to the intervention group will use the investigational medical device, ZeusOSA, which delivers transcutaneous electrical stimulation to the upper airway dilator muscles during sleep. The device is intended for nightly use at home over a three-month period. Participants in the usual care group will continue with ongoing CPAP therapy in accordance with current clinical practice.
All participants will undergo baseline assessments prior to randomisation, including a home-based sleep study conducted without treatment. Follow-up will include a scheduled telephone contact at approximately six weeks and a repeat assessment at three months, including a further home-based sleep study conducted with the assigned treatment and receive standard advice on sleep hygiene and lifestyle measures. The patients will then be referred for follow up to standard care in the outpatient setting at their respective sleep centre. The trial duration including recruitment is 3 years.
The study will assess the therapeutic effects of the investigational medical device on sleep-related outcomes and symptoms, as well as participant-reported quality of life. Additional objectives include evaluation of treatment adherence, comfort and acceptability of use, and monitoring of adverse events. Data collected during the study will also be used to support an assessment of healthcare resource use associated with the intervention.
The study is designed to reflect real-world use of the investigational medical device in a domiciliary setting and to identify patient characteristics associated with response to treatment. Results from this trial will inform the future clinical and regulatory development of the device for the management of obstructive sleep apnoea.
2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.
This study's planned enrollment of 186 is above the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with Zeus Sleep Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous Positive Airway Pressure (CPAP)
Device: CPAP
Transcutaneous Electrical Stimulation (ZeusOSA)
Device: ZeusOSA
Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.
Continous positive airway pressure (CPAP) when asleep
Apnea-hypopnea-index (AHI)
Number of respiratory events per hour measured by home-based sleep study.
Time frame: Baseline to 3 months
Epworth Sleepiness Scale (ESS)
Daytime sleepiness measured using the Epworth Sleepiness Scale (score range 0-24, with higher scores indicating greater sleepiness).
Time frame: Baseline to 3 months
EQ-5D Index Score
Health-related quality of life measured using the EQ-5D descriptive system (index score 0-1).
Time frame: Baseline to 3 months
EQ-5D Visual Analogue Scale (VAS) Score
Self-rated health measured using the EQ-5D visual analogue scale (0-100, with higher scores indicating better perceived health).
Time frame: Baseline to 3 months
Functional Outcome of Sleep Questionnaire (FOSQ-10) Score
Sleep-related functional status measured using the FOSQ-10, with higher scores indicating better functional outcomes.
Time frame: Baseline to 3 months
Snoring Duration
Total duration of snoring measured during sleep, expressed in minutes.
Time frame: Baseline to 3 months
Snoring Intensity
Average snoring intensity measured in decibels during sleep.
Time frame: Baseline to 3 months
Adherence Average hours/night
Average nightly usage (hours) of the assigned treatment.
Time frame: Baseline to 3 months
Adherence - Percentage of Nights Used
Percentage of nights the assigned treatment was used during the study period.
Time frame: Baseline to 3 months
4% ODI (Oxygen Desaturation Index)
ODI refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥ 4% (over the last 120 seconds) that lasts for at least 10 seconds.
Time frame: Baseline to 3 months
SHER15 criteria defining responders to treatment
Reduction of AHI of more than 50% to below 15 events per hour, or normal (below 5 per hour);
Time frame: 3-months
SHER20 criteria defining responders to treatment
Reduction of AHI of more than 50% to below 20 events per hour, or normal (below 5 per hour);
Time frame: 3-months
Gender-related response
Responder rate according to gender (male vs female responders, percentage)
Time frame: 3-months
Cost-Effectiveness
Cost-effectiveness of ZeusOSA compared to usual care (ongoing CPAP) in patients with low CPAP adherence, expressed as incremental cost-effectiveness ratios (ICERs). ICERs are a composite measure which will be derived from: proportion of responders, quality of life (EQ-5D-5L), and healthcare resource use/cost data.
Time frame: 3 months
Socioeconomic Group/Area-related response
Responder rate according to socioeconomic area (Index of Multiple Deprivation decile 1-10), percentage
Time frame: 3-months
No study locations are listed for this record.
Plan to share: Undecided — Pending ethics approval and medio-legal framework (GDPR)
Start is estimated for Sep 2026; primary completion for Jan 2028, 16 months later.
Of 116 industry-sponsored interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 16 months is above that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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