Obstructive Sleep ApneaTESLA-homeNCT03160456
Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea
A study testing Transcutaneous electrical stimulation and Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community compared to usual care, and follow the patients for three months, as well as to assess compliance of non-invasive electrical stimulation… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Transcutaneous electrical stimulation and Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2018to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild-moderate OSA (AHI 5-35/hour)
- difficulties with or failed CPAP and/or withdrawn from standard care (CPAP <4hours/night)
- Body mass index (BMI) 18.5-32 kg/m2
- No significant anatomical obstruction in the upper airway (e.g. normal sized tonsils).
Who cannot join
- No OSA (AHI <5/h)
- Severe obstructive sleep apnoea (AHI>35/hour)
- Exclusively postural sleep apnoea
- isolated Rapid-Eye-Movement (REM) sleep associated OSA
- Cachexia (BMI <18.5 kg/m2)
- Obesity (BMI >32 kg/m2)
Show all 24Show fewer
- Hypercapnic respiratory failure (pCO2>6.5 kPa)
- Features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- >28mmol/L).
- enlarged tonsils (size 3-4)
- polyps and adenoids
- neuromuscular disease
- hypoglossal nerve palsy
- abnormal pulmonary function tests
- severe pulmonary hypertension
- valvular heart disease
- heart failure (New York Heart Association, NYHA III-IV)
- myocardial infarction and significant cardiac arrhythmias
- uncontrolled hypertension
- active psychiatric disease
- co-existing non-respiratory sleep disorder
- significant metal implants or cardiac/other pacemakers.
- facial hair that affects the correct placement of the hydrogel patch
- endoscopically identified contraindication to upper airway stimulation (multi-level obstruction)
- These criteria are consistent with our experience from previous trials using transcutaneous electrical stimulation in OSA and likely to identify potential responders; these criteria are also similar to those from trials using hypoglossal nerve stimulation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Randomised Controlled Trial of Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community compared to usual care, and follow the patients for three months, as well as to assess compliance of non-invasive electrical stimulation of the upper airway dilator muscles in obstructive sleep apnoea patients over time and evaluate the control of symptoms and improvement in quality of life.
Read the detailed description
Obstructive sleep apnoea is highly prevalent, with the obesity epidemic increasing the problem. The best treatment for uncomplicated and moderate-severe OSA remains CPAP therapy. However, long-term adherence to treatment with CPAP is poor and there are few alternatives. Electrical stimulation of the dilator muscles of the upper airway has been shown to reduce nocturnal apnoeas significantly using an invasive approach, hypoglossal nerve stimulation, as well as by non-invasive transcutaneous stimulation. Although non-invasive transcutaneous stimulation may not be as effective as CPAP therapy in many OSA patients it could be an important option to treat some of the large number of patients who fail CPAP and might also be of use in those whose OSA is not judged sufficiently severe to warrant CPAP.
The investigators propose a study to use a transcutaneous electrical stimulation device in selected patients with OSA who do not tolerate CPAP therapy following assessment of the upper airway. Participants will undergo a baseline sleep study (polysomnography/home-based respiratory polygraphy). Following minimisation for gender (male/female) and OSA severity (mild/moderate-severe) they will be randomised into active treatment arm (transcutaneous electrical stimulation) or usual care (ongoing CPAP therapy). Patients will be treated over a period of 3-months in the community, re-assessed (including polysomnography/home-based respiratory polygraphy) and the results will be compared against usual care, ongoing CPAP therapy. This study will help to prepare a definitive multi-centre randomized controlled trial using the non-invasive method of upper airway stimulation in OSA.
The primary aim of this study is to assess efficacy and generate an accurate sample size estimation, test the subjective willingness of patients to use and objectively determined compliance with the treatment over a long period, as well as to specify the drop-out rate. The improvement in sleep apnoea will be the primary outcome measures. The symptomatic response, feasibility of the method, including compliance, comfort, adverse events, will be the secondary outcome measure. An ad-hoc analysis will be performed in the responder group (improvement in the apnoea-hypopnea index (AHI) by >50% from baseline OR improvement in the 4% oxygen-desaturation index (ODI) >25% from baseline OR AHI/4%ODI <5/hour at follow up).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Transcutaneous electrical stimulation, Continuous positive airway pressure
- Keywords
- upper airway, genioglossus, CPAP, electrical stimulation, sleep, sleep disordered breathing
- 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.
Transcutaneous electrical stimulationDevice
Also called TESLA home
The device needs to be started by pressing the 'on' button. Once the device is turned on the current intensity can be increased by pushing the '+' button and lowered by pushing the '-' button. When a comfortable skin sensation is felt the patients should press the '-' button once more. At that time the device stimulates with a low current which is not felt but provides a neuromuscular tone to the muscles whilst asleep. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Once disconnected it should be turned off by pressing the 'off' button.
Continuous positive airway pressureDevice
Also called CPAP (usual care)
CPAP will be applied according to usual clinical care, the follow up will be organised in the same way as the active intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical stimulation | Experimental | The group of participants receiving continuous transcutaneous electrical stimulation will be trained on the device and settings will be recorded. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At each visit comfort, compliance and adverse reactions will be recorded. At 12-weeks, the patients will be invited for a repeat assessment including polysomnography/home-based respiratory polygraphy during a night of electrical stimulation. Usage time of the device will be discussed with the patients and recorded. Receives: Device: Transcutaneous electrical stimulation |
| Continuous positive airway pressure (usual care) | Active comparator | Participants who will be randomized to the usual care group will be given their own CPAP device, as previously prescribed. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At the last visit, the patients will be studied during a repeat inpatient polysomnography/home-based respiratory polygraphy and the initial assessment will be repeated. Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnoea Hypopnoea Index
AHI
Measured: 3 months
Secondary outcomes (10)
Epworth Sleepiness Scale
ESS (0-24 points)
Measured: 3 months
Oxygen Desaturation Index
4%ODI (x hour-1)
Measured: 3 months
Usage of treatment
Usage per night (average hours)
Measured: 3 months
Compliance with treatment
Percentage of nights used (%)
Measured: 3 months
Acceptance of device
Visual analogue scale (points, 0-10)
Measured: 3 months
Sleep related quality of life
FOSQ
Measured: 3 months
Snoring
Percentage of the night (%)
Measured: 3 months
Genioglossus contraction
Ultrasound (thickness, mm)
Measured: 3 months
General quality of life
EQ-5D
Measured: 3 months
Anatomy of upper airway
Endoscopically identified diameter (mm)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start18 Jun 2018
- Primary completion8 Feb 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Randomised parallel group controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Joerg Steier, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Joerg Steier, MD, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation TrustJohn Moxham, MD, Study chair, King's College LondonMichael I Polkey, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustKai Lee, MD, Principal investigator, King's College London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160456
- Sponsor's protocol ID
- Version 1.3 / 22-11-2020
- Other IDs
- 217448, 18/LO/0638
- Acronym
- TESLA-home
- Status last verified
- May 2023
- First submitted
- 16 May 2017
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, upon request to the authors.
Publications
Pengo MF, Steier J. Emerging technology: electrical stimulation in obstructive sleep apnoea. J Thorac Dis. 2015 Aug;7(8):1286-97. doi: 10.3978/j.issn.2072-1439.2014.04.04.
PubMed 26380757Bisogni V, Pengo MF, De Vito A, Maiolino G, Rossi GP, Moxham J, Steier J. Electrical stimulation for the treatment of obstructive sleep apnoea: a review of the evidence. Expert Rev Respir Med. 2017 Sep;11(9):711-720. doi: 10.1080/17476348.2017.1358619. Epub 2017 Jul 27.
PubMed 28730908Pengo 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 27435610Campbell T, Pengo MF, Steier J. Patients' preference of established and emerging treatment options for obstructive sleep apnoea. J Thorac Dis. 2015 May;7(5):938-42. doi: 10.3978/j.issn.2072-1439.2015.04.53.
PubMed 26101652Steier 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 21454399Ratneswaran D, Cheng M, Nasser E, Madula R, Pengo M, Hope K, Schwarz EI, Luo Y, Kaltsakas G, Polkey MI, Moxham J, Steier J. Domiciliary transcutaneous electrical stimulation in patients with obstructive sleep apnoea and limited adherence to continuous positive airway pressure therapy: a single-centre, open-label, randomised, controlled phase III trial. EClinicalMedicine. 2023 Aug 3;62:102112. doi: 10.1016/j.eclinm.2023.102112. eCollection 2023 Aug.
PubMed 37654667
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT03160456
- Acronym / sponsor ID
- TESLA-home / Version 1.3 / 22-11-2020
- Conditions
- Obstructive Sleep Apnea
- Keywords
- upper airway, genioglossus, CPAP, electrical stimulation, sleep, sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 19 May 2017 (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 aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community compared to usual care, and follow the patients for three months, as well as to assess compliance of non-invasive electrical stimulation of the upper airway dilator muscles in obstructive sleep apnoea patients over time and evaluate the control of symptoms and improvement in quality of life.
Detailed description
Obstructive sleep apnoea is highly prevalent, with the obesity epidemic increasing the problem. The best treatment for uncomplicated and moderate-severe OSA remains CPAP therapy. However, long-term adherence to treatment with CPAP is poor and there are few alternatives. Electrical stimulation of the dilator muscles of the upper airway has been shown to reduce nocturnal apnoeas significantly using an invasive approach, hypoglossal nerve stimulation, as well as by non-invasive transcutaneous stimulation. Although non-invasive transcutaneous stimulation may not be as effective as CPAP therapy in many OSA patients it could be an important option to treat some of the large number of patients who fail CPAP and might also be of use in those whose OSA is not judged sufficiently severe to warrant CPAP.
The investigators propose a study to use a transcutaneous electrical stimulation device in selected patients with OSA who do not tolerate CPAP therapy following assessment of the upper airway. Participants will undergo a baseline sleep study (polysomnography/home-based respiratory polygraphy). Following minimisation for gender (male/female) and OSA severity (mild/moderate-severe) they will be randomised into active treatment arm (transcutaneous electrical stimulation) or usual care (ongoing CPAP therapy). Patients will be treated over a period of 3-months in the community, re-assessed (including polysomnography/home-based respiratory polygraphy) and the results will be compared against usual care, ongoing CPAP therapy. This study will help to prepare a definitive multi-centre randomized controlled trial using the non-invasive method of upper airway stimulation in OSA.
The primary aim of this study is to assess efficacy and generate an accurate sample size estimation, test the subjective willingness of patients to use and objectively determined compliance with the treatment over a long period, as well as to specify the drop-out rate. The improvement in sleep apnoea will be the primary outcome measures. The symptomatic response, feasibility of the method, including compliance, comfort, adverse events, will be the secondary outcome measure. An ad-hoc analysis will be performed in the responder group (improvement in the apnoea-hypopnea index (AHI) by >50% from baseline OR improvement in the 4% oxygen-desaturation index (ODI) >25% from baseline OR AHI/4%ODI <5/hour at follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised parallel group controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical stimulation | Experimental | Device: Transcutaneous electrical stimulationThe group of participants receiving continuous transcutaneous electrical stimulation will be trained on the device and settings will be recorded. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At each visit comfort, compliance and adverse reactions will be recorded. At 12-weeks, the patients will be invited for a repeat assessment including polysomnography/home-based respiratory polygraphy during a night of electrical stimulation. Usage time of the device will be discussed with the patients and recorded. |
| Continuous positive airway pressure (usual care) | Active comparator | Device: Continuous positive airway pressureParticipants who will be randomized to the usual care group will be given their own CPAP device, as previously prescribed. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At the last visit, the patients will be studied during a repeat inpatient polysomnography/home-based respiratory polygraphy and the initial assessment will be repeated. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mild-moderate OSA (AHI 5-35/hour)
- difficulties with or failed CPAP and/or withdrawn from standard care (CPAP <4hours/night)
- Body mass index (BMI) 18.5-32 kg/m2
- No significant anatomical obstruction in the upper airway (e.g. normal sized tonsils).
Key exclusion criteria (24 listed)
- No OSA (AHI <5/h)
- Severe obstructive sleep apnoea (AHI>35/hour)
- Exclusively postural sleep apnoea
- isolated Rapid-Eye-Movement (REM) sleep associated OSA
- Cachexia (BMI <18.5 kg/m2)
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 stimulationAlso: TESLA homeThe device needs to be started by pressing the 'on' button. Once the device is turned on the current intensity can be increased by pushing the '+' button and lowered by pushing the '-' button. When a comfortable skin sensation is felt the patients should press the '-' button once more. At that time the device stimulates with a low current which is not felt but provides a neuromuscular tone to the muscles whilst asleep. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Once disconnected it should be turned off by pressing the 'off' button. | Device | Transcutaneous electrical stimulation |
| Continuous positive airway pressureAlso: CPAP (usual care)CPAP will be applied according to usual clinical care, the follow up will be organised in the same way as the active intervention group. | Device | Continuous positive airway pressure (usual care) |
Primary outcome
Apnoea Hypopnoea Index
Time frame: 3 months
AHI
10 secondary outcomes
Epworth Sleepiness Scale
Time frame: 3 months
Oxygen Desaturation Index
Time frame: 3 months
Usage of treatment
Time frame: 3 months
Compliance with treatment
Time frame: 3 months
Acceptance of device
Time frame: 3 months
Sleep related quality of life
Time frame: 3 months
Snoring
Time frame: 3 months
Genioglossus contraction
Time frame: 3 months
General quality of life
Time frame: 3 months
Anatomy of upper airway
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 26380757Pengo MF, Steier J. Emerging technology: electrical stimulation in obstructive sleep apnoea. J Thorac Dis. 2015 Aug;7(8):1286-97. doi: 10.3978/j.issn.2072-1439.2014.04.04.
- Background: PubMed 28730908Bisogni V, Pengo MF, De Vito A, Maiolino G, Rossi GP, Moxham J, Steier J. Electrical stimulation for the treatment of obstructive sleep apnoea: a review of the evidence. Expert Rev Respir Med. 2017 Sep;11(9):711-720. doi: 10.1080/17476348.2017.1358619. Epub 2017 Jul 27.
- Results publication: 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.
- Results publication: PubMed 26101652Campbell T, Pengo MF, Steier J. Patients' preference of established and emerging treatment options for obstructive sleep apnoea. J Thorac Dis. 2015 May;7(5):938-42. doi: 10.3978/j.issn.2072-1439.2015.04.53.
- 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 37654667Ratneswaran D, Cheng M, Nasser E, Madula R, Pengo M, Hope K, Schwarz EI, Luo Y, Kaltsakas G, Polkey MI, Moxham J, Steier J. Domiciliary transcutaneous electrical stimulation in patients with obstructive sleep apnoea and limited adherence to continuous positive airway pressure therapy: a single-centre, open-label, randomised, controlled phase III trial. EClinicalMedicine. 2023 Aug 3;62:102112. doi: 10.1016/j.eclinm.2023.102112. eCollection 2023 Aug.
- Open access link to a review about invasive and non-invasive electrical stimulation in sleep apnoeaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Yes, upon request to the authors.
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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 and St Thomas' NHS Foundation Trust
John Moxham, MD study chair
King's College London
Michael I Polkey, PhD principal investigator
Royal Brompton & Harefield 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 and Continuous positive airway pressure in people with Obstructive Sleep Apnea, 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 4 inclusion and 24 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 9 May 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apnoea Hypopnoea Index (time frame: 3 months). 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 NCT03160456, which also lists 6 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 9 May 2023.