Obstructive Sleep ApneaTESLA-MICRONNCT07343362
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
A study testing ZeusOSA and CPAP in people with Obstructive Sleep Apnea, run by Zeus Sleep Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ZeusOSA and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour, as measured by the baseline sleep study (3 nights off CPAP).
- If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours/night on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.
- Adults with a body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive)
- Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).
- Able and willing to provide informed written consent.
- Access to a smartphone and internet at home.
Who cannot join
- Hypercapnic patients (pCO2>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- >28mmol/L).
- Adults with significantly enlarged tonsils (size 3-4)
- Adults with polyps or adenoids, hypoglossal nerve palsy,
- Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension).
- Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.
- Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps.
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- Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device.
- Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device
- Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave.
- Participants with an allergy to plasters or similar products.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Salma Ayyis, PhD contact
About this study
Official title: Zeus Sleep Technology: A UK-based Multi-centre Randomised Controlled Trial Using Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea (TESLA)
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ZeusOSA, CPAP
- Keywords
- CPAP, Continuous Positive Airway Pressure, Hypoglossal Nerve Stimulation, non-CPAP therapy, sleep-disordered breathing, TESLA-MICRON, Zeus Sleep Technology, transcutaneous electrical stimulation, Zeus Sleep Ltd
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeusOSADevice
Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.
CPAPDevice
Continous positive airway pressure (CPAP) when asleep
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Continuous Positive Airway Pressure (CPAP) Receives: Device: CPAP |
| Intervention | Experimental | Transcutaneous Electrical Stimulation (ZeusOSA) Receives: Device: ZeusOSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea-index (AHI)
Number of respiratory events per hour measured by home-based sleep study.
Measured: Baseline to 3 months
Secondary outcomes (9)
Epworth Sleepiness Scale (ESS)
Daytime sleepiness measured using the Epworth Sleepiness Scale (score range 0-24, with higher scores indicating greater sleepiness).
Measured: Baseline to 3 months
EQ-5D Index Score
Health-related quality of life measured using the EQ-5D descriptive system (index score 0-1).
Measured: 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).
Measured: 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.
Measured: Baseline to 3 months
Snoring Duration
Total duration of snoring measured during sleep, expressed in minutes.
Measured: Baseline to 3 months
Snoring Intensity
Average snoring intensity measured in decibels during sleep.
Measured: Baseline to 3 months
Adherence Average hours/night
Average nightly usage (hours) of the assigned treatment.
Measured: Baseline to 3 months
Adherence - Percentage of Nights Used
Percentage of nights the assigned treatment was used during the study period.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, parallel, interventional randomized controlled trial Sample Size Calculation The sample size estimates were based on the previous trial by Ratneswaran et al. 2023 (eClinMed) where the primary outcome was change in mean apnea-hypopnea index (AHI) at 3-months between two trial arms. The difference adjusted for the baseline value was -7.0 (95% CI: -15.7;1.8), and the common standard deviation within group was 18. Using these estimates for an analysis of covariance, sample sizes of 74, and 74 are required from each of the 2 trial groups whose means are to be compared. The covariate was assumed to have an R-squared of 0.30. The total sample of 148 subjects achieves 80% power to detect the differences described by Ratneswaran between the two means, with 0.05 00 significance level. Allowing for 20% dropout the sample required is 186 participants in the two groups.
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeus Sleep Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College London, Royal Brompton & Harefield NHS Foundation Trust, Queen Victoria Hospital NHS Foundation Trust, The Queen Elizabeth Hospital, Imperial College Healthcare NHS Trust, AintreeNHSTrust, University of Southampton, Royal Papworth Hospital
- Responsible party
- Sponsor
- Investigators
- Joerg Steier, PhD, Study chair, Guy's & St Thomas' NHS Foundation Trust, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343362
- Sponsor's protocol ID
- ZEUSi4i-1.0-03/12/25
- Other IDs
- NIHR209411
- Acronym
- TESLA-MICRON
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending ethics approval and medio-legal framework (GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zeus Sleep Technology: A UK-based Multi-centre Randomised Controlled Trial Using Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea (TESLA)
- ClinicalTrials.gov ID
- NCT07343362
- Acronym / sponsor ID
- TESLA-MICRON / ZEUSi4i-1.0-03/12/25
- Conditions
- Obstructive Sleep Apnea
- Keywords
- CPAP, Continuous Positive Airway Pressure, Hypoglossal Nerve Stimulation, non-CPAP therapy, sleep-disordered breathing, TESLA-MICRON, Zeus Sleep Technology, transcutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Zeus Sleep LtdIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, King's College London, Royal Brompton & Harefield NHS Foundation Trust, Queen Victoria Hospital NHS Foundation Trust, The Queen Elizabeth Hospital, Imperial College Healthcare NHS Trust, AintreeNHSTrust, University of Southampton, Royal Papworth Hospital
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group, parallel, interventional randomized controlled trial Sample Size Calculation The sample size estimates were based on the previous trial by Ratneswaran et al. 2023 (eClinMed) where the primary outcome was change in mean apnea-hypopnea index (AHI) at 3-months between two trial arms. The difference adjusted for the baseline value was -7.0 (95% CI: -15.7;1.8), and the common standard deviation within group was 18. Using these estimates for an analysis of covariance, sample sizes of 74, and 74 are required from each of the 2 trial groups whose means are to be compared. The covariate was assumed to have an R-squared of 0.30. The total sample of 148 subjects achieves 80% power to detect the differences described by Ratneswaran between the two means, with 0.05 00 significance level. Allowing for 20% dropout the sample required is 186 participants in the two groups.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Device: CPAPContinuous Positive Airway Pressure (CPAP) |
| Intervention | Experimental | Device: ZeusOSATranscutaneous Electrical Stimulation (ZeusOSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour, as measured by the baseline sleep study (3 nights off CPAP).
- If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours/night on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.
- Adults with a body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive)
- Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).
- Able and willing to provide informed written consent.
Key exclusion criteria (10 listed)
- Hypercapnic patients (pCO2>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- >28mmol/L).
- Adults with significantly enlarged tonsils (size 3-4)
- Adults with polyps or adenoids, hypoglossal nerve palsy,
- Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension).
- Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZeusOSATranscutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep. | Device | Intervention |
| CPAPContinous positive airway pressure (CPAP) when asleep | Device | Usual Care |
Primary outcome
Apnea-hypopnea-index (AHI)
Time frame: Baseline to 3 months
Number of respiratory events per hour measured by home-based sleep study.
9 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: Baseline to 3 months
EQ-5D Index Score
Time frame: Baseline to 3 months
EQ-5D Visual Analogue Scale (VAS) Score
Time frame: Baseline to 3 months
Functional Outcome of Sleep Questionnaire (FOSQ-10) Score
Time frame: Baseline to 3 months
Snoring Duration
Time frame: Baseline to 3 months
Snoring Intensity
Time frame: Baseline to 3 months
Adherence Average hours/night
Time frame: Baseline to 3 months
Adherence - Percentage of Nights Used
Time frame: Baseline to 3 months
4% ODI (Oxygen Desaturation Index)
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. Pending ethics approval and medio-legal framework (GDPR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salma Ayyis, PhD contact
Joerg Steier, PhD study chair
Guy's & St Thomas' NHS Foundation Trust, London, UK
Questions about this trial
What is this clinical trial studying?
A study testing ZeusOSA and CPAP in people with Obstructive Sleep Apnea, run by Zeus Sleep Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nigel Clarke, CEO (+442071883434 ext. x83435, support@zeussleeps.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea-index (AHI) (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.