Obstructive Sleep ApnoeaTESLANCT01661712
Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea
A study testing Transcutaneous electrical stimulation in people with Obstructive Sleep Apnoea, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnoea
- What is being tested?
- Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI ≥15/h or sleep apnoea with an ODI ≥5/h plus an Epworth sleepiness score >10.
Who cannot join
- morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blinded, Sham-controlled Cross-over Trial of Continuous Transcutaneous Electrical Stimulation of the Pharyngeal Dilator Muscles in Obstructive Sleep Apnoea
The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing.
Read the detailed description
Obstructive sleep apnoea is the most common problem of sleep-disordered breathing. It affects at least four percent of the male and two percent of the female adult population. It is associated with excessive daytime sleepiness, causing significant disturbance of daytime routines affecting work, social life and memory; untreated, it also causes a significant cardiovascular and metabolic risk. The best available treatment for obstructive sleep apnoea is continuous positive airway pressure (CPAP). However, not everyone eligible tolerates this treatment because it requires them to sleep with a nasal or full-face mask that is connected by a tube to a machine. Although CPAP is recommended by the National Institute for Health and Clinical Excellence (NICE) for moderate-severe sleep apnoea, approximately one third of sleep apnoea patients who should be on CPAP stop therapy within five years. Mild sleep apnoea is currently treated with mandibular advancement splints and generic sleep hygiene advice.
Continuous transcutaneous electrical stimulation (CTES) of the submental region activates the muscles that dilate the upper airway. This is where airway obstruction occurs in sleep apnoea. It has been shown that CTES at night for short periods (10minutes) effectively stimulates the genioglossus muscle, the strongest pharyngeal dilator and reduces upper airway obstruction, work of breathing and neural respiratory drive in patients with sleep apnoea. The London Respiratory Muscle Groups, based within King's Health Partners and the Royal Brompton Hospital, has developed a CTES stimulator device. This device senses apnoeas and snoring and delivers CTES until normal ventilation has been restored.
We propose to undertake a randomized, double-blinded, sham-controlled cross-over trial with sleep apnoea patients to evaluate the efficacy of this method. Patients will be randomly assigned to a night of CTES or sham-stimulation. The primary outcome measure is the number of oxygen desaturations per hour (ODI) caused by apnoeas and the secondary outcome measures are sleepiness, as measured by the Epworth sleepiness score, the apnoea-hypopnoea-index (AHI) and comfort, as assessed by a visual analogue score. The sample size Calculation using data from our own published pilot study revealed that this study would require 44 patients to be enroled. The mean study duration until all outcomes will be assessed for each patient will be four weeks. We plan to commence the study in winter 2012/13 for a period of two years, including analysis and publication, to be concluded in December 2014.
- Conditions
- Obstructive Sleep Apnoea
- Being tested
- Transcutaneous electrical stimulation, Sham stimulation
- Keywords
- obstructive sleep apnoea,, continuous transcutaneous electrical stimulation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDevice
Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation)
Sham stimulationDevice
Sham stimulation for one night (no electrical stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical stimulation | Active comparator | One night of transcutaneous electrical stimulation (electrical current titrated according to skin sensation) Receives: Device: Transcutaneous electrical stimulation |
| Sham stimulation | Sham comparator | One night of sham stimulation (no electrical current) Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
4% Oxygen Desaturation Index (ODI, 4%)
The primary outcome measure for this trial is the 4% oxygen desaturation index (ODI, 4%) per hour of sleep (h-1). The 4% ODI was chosen as primary outcome parameter over the AHI because an incomplete re-opening of the upper airway during an ongoing apnoeic effort caused by transcutaneous electrical stimulation (CTES) may result in a nominal increase of the AHI. We consider that the 4% ODI would be a more robust marker for the severity of sleep apnoea, low average oxygen levels indicating obesity-hypoventilation syndrome which will be an exclusion criterion.
Although a specific cut off is not well defined a 4% ODI ≥5 represent mild OSA whilst a 4% ODI ≥15 represents moderate-severe OSA. Normal range is usually considered 0-5 events/hour.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Secondary outcomes (5)
Apnoea-Hypopnoea Index (AHI)
The Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. An apnea (pause in breathing) is defined by a temporary cessation of breathing that must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A hypopnoea is a reduction of ventilation (shallow breathing) but not a complete cessation of breathing, lasting al least 10 seconds and associated with a decrease in blood oxygenation.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Nadir Oxygenation
The nadir oxygenation (lowest SpO2, %) during the sleep study is measured while the patients are asleep.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Patient Comfort
Patient comfort during the sleep study, as measured by a visual analogue scale (0-10 points). Higher values in the scale range represent a better outcome.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Device Acceptance
Device acceptance during sleep study, as measured by a visual analogue scale (0-10points). Higher values in the scale range represent a better outcome.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Sleepiness
Daytime sleepiness as an ad-hoc measurement, as measured by the Stanford Sleepiness Scale (0-7 points, x). Higher values in the scale range represent more severe sleepiness.
Measured: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Steier, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Joerg Steier, MD, PhD, Principal investigator, Guy´s & St Thomas´ NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661712
- Sponsor's protocol ID
- SOSATS2012-V1.0-01/08/2012
- Acronym
- TESLA
- Status last verified
- Nov 2018
- First submitted
- 2 Aug 2012
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Steier J, Seymour J, Rafferty GF, Jolley CJ, Solomon E, Luo Y, Man WD, Polkey MI, Moxham J. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011 Oct;140(4):998-1007. doi: 10.1378/chest.10-2614. Epub 2011 Mar 31.
PubMed 21454399Pengo MF, Xiao S, Ratneswaran C, Reed K, Shah N, Chen T, Douiri A, Hart N, Luo Y, Rafferty GF, Rossi GP, Williams A, Polkey MI, Moxham J, Steier J. Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea. Thorax. 2016 Oct;71(10):923-31. doi: 10.1136/thoraxjnl-2016-208691. Epub 2016 Jul 19.
PubMed 27435610
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blinded, Sham-controlled Cross-over Trial of Continuous Transcutaneous Electrical Stimulation of the Pharyngeal Dilator Muscles in Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT01661712
- Acronym / sponsor ID
- TESLA / SOSATS2012-V1.0-01/08/2012
- Conditions
- Obstructive Sleep Apnoea
- Keywords
- obstructive sleep apnoea,, continuous transcutaneous electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing.
Detailed description
Obstructive sleep apnoea is the most common problem of sleep-disordered breathing. It affects at least four percent of the male and two percent of the female adult population. It is associated with excessive daytime sleepiness, causing significant disturbance of daytime routines affecting work, social life and memory; untreated, it also causes a significant cardiovascular and metabolic risk. The best available treatment for obstructive sleep apnoea is continuous positive airway pressure (CPAP). However, not everyone eligible tolerates this treatment because it requires them to sleep with a nasal or full-face mask that is connected by a tube to a machine. Although CPAP is recommended by the National Institute for Health and Clinical Excellence (NICE) for moderate-severe sleep apnoea, approximately one third of sleep apnoea patients who should be on CPAP stop therapy within five years. Mild sleep apnoea is currently treated with mandibular advancement splints and generic sleep hygiene advice.
Continuous transcutaneous electrical stimulation (CTES) of the submental region activates the muscles that dilate the upper airway. This is where airway obstruction occurs in sleep apnoea. It has been shown that CTES at night for short periods (10minutes) effectively stimulates the genioglossus muscle, the strongest pharyngeal dilator and reduces upper airway obstruction, work of breathing and neural respiratory drive in patients with sleep apnoea. The London Respiratory Muscle Groups, based within King's Health Partners and the Royal Brompton Hospital, has developed a CTES stimulator device. This device senses apnoeas and snoring and delivers CTES until normal ventilation has been restored.
We propose to undertake a randomized, double-blinded, sham-controlled cross-over trial with sleep apnoea patients to evaluate the efficacy of this method. Patients will be randomly assigned to a night of CTES or sham-stimulation. The primary outcome measure is the number of oxygen desaturations per hour (ODI) caused by apnoeas and the secondary outcome measures are sleepiness, as measured by the Epworth sleepiness score, the apnoea-hypopnoea-index (AHI) and comfort, as assessed by a visual analogue score. The sample size Calculation using data from our own published pilot study revealed that this study would require 44 patients to be enroled. The mean study duration until all outcomes will be assessed for each patient will be four weeks. We plan to commence the study in winter 2012/13 for a period of two years, including analysis and publication, to be concluded in December 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical stimulation | Active comparator | Device: Transcutaneous electrical stimulationOne night of transcutaneous electrical stimulation (electrical current titrated according to skin sensation) |
| Sham stimulation | Sham comparator | Device: Sham stimulationOne night of sham stimulation (no electrical current) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI ≥15/h or sleep apnoea with an ODI ≥5/h plus an Epworth sleepiness score >10.
Key exclusion criteria (1 listed)
- morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with oxygen saturation (SpO2) less than 90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants).
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 |
|---|---|---|
| Transcutaneous electrical stimulationTranscutaneous electrical stimulation (one night of electrical current titrated according to skin sensation) | Device | Transcutaneous electrical stimulation |
| Sham stimulationSham stimulation for one night (no electrical stimulation) | Device | Sham stimulation |
Primary outcome
4% Oxygen Desaturation Index (ODI, 4%)
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
The primary outcome measure for this trial is the 4% oxygen desaturation index (ODI, 4%) per hour of sleep (h-1). The 4% ODI was chosen as primary outcome parameter over the AHI because an incomplete re-opening of the upper airway during an ongoing apnoeic effort caused by transcutaneous electrical stimulation (CTES) may result in a nominal increase of the AHI. We consider that the 4% ODI would be a more robust marker for the severity of sleep apnoea, low average oxygen levels indicating obesity-hypoventilation syndrome which will be an exclusion criterion. Although a specific cut off is not well defined a 4% ODI ≥5 represent mild OSA whilst a 4% ODI ≥15 represents moderate-severe OSA. Normal range is usually considered 0-5 events/hour.
5 secondary outcomes
Apnoea-Hypopnoea Index (AHI)
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Nadir Oxygenation
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Patient Comfort
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Device Acceptance
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Sleepiness
Time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21454399Steier J, Seymour J, Rafferty GF, Jolley CJ, Solomon E, Luo Y, Man WD, Polkey MI, Moxham J. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011 Oct;140(4):998-1007. doi: 10.1378/chest.10-2614. Epub 2011 Mar 31.
- Derived from this study: PubMed 27435610Pengo MF, Xiao S, Ratneswaran C, Reed K, Shah N, Chen T, Douiri A, Hart N, Luo Y, Rafferty GF, Rossi GP, Williams A, Polkey MI, Moxham J, Steier J. Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea. Thorax. 2016 Oct;71(10):923-31. doi: 10.1136/thoraxjnl-2016-208691. Epub 2016 Jul 19.
- Guy's \& St Thomas' National Health Service (NHS) Foundation Trust homepageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Joerg Steier, MD, PhD principal investigator
Guy´s & St Thomas´ NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation in people with Obstructive Sleep Apnoea, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4% Oxygen Desaturation Index (ODI, 4%) (time frame: 1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661712, which also lists 2 linked publications.
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 6 Dec 2018.