Obstructive Sleep ApneaIPOSATNCT04092660
Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.
A study testing Behaviour change Intervention Based on Health Action Process Approach Model and Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard in people with Obstructive Sleep Apnea, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Behaviour change Intervention Based on Health Action Process Approach Model and Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2019to 1 Jun 2026
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 40 years old)
- Confirmed diagnosis of OSA (AHI ≥ 5)
- Referred for MAA therapy
- Must be able to understand, read and write English; with the assistance of a translator
Who cannot join
- Insufficient teeth for MAA fabrication
- Poor dental and/or periodontal health
- Symptomatic Temporomandibular Disorder (TMD)
- Previously used an MAA
- Patients with Epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Dental Hospital
London, E1 2AD
Ama Johal, 138651, a.s.johal@qmul.ac.uk
Harishri Tallamraju, 07788128535, h.tallamraju@qmul.ac.uk
About this study
Official title: Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care.
The investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index >5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA.
Patients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.
Read the detailed description
The present study aims to assess whether special support approaches i.e. Interventions influence patients with Obstructive sleep apnoea (OSA), to use the Mandibular Advancement Appliance (MAA) or the anti-snoring mouth guard, more as compared to those who receive standard care.
Factors such as mood, anxiety, stress, depression, socioeconomic status, and social support play an important role in the ability of the patients to make decisions about using the appliance. Thus, the investigators also aim to explore the potential role these factors play in the decision-making process to help future patients make most of their treatments.
Patients meeting the selection criteria will be provided with a patient information leaflet, explaining the whole study. Interested patients will be asked to sign the Informed Consent, after which they will be randomly assigned into two groups- Intervention Care group (IC) and Standardized Care group (SCG).
Patients will be provided with a sleep diary to record their hours of sleep and usage of MAA, which will give a subjective record of the adherence (duration of usage of MAA) and an objective record of the adherence will be collected from a sensor present in the MAA.
At Initial Screening, the patient's age, gender, body mass index (BMI) and neck circumference will be recorded. Patients in the IC group will receive a Health Pamphlet about OSA, specially designed for this study. The IC group's knowledge of OSA will be assessed along with their partner's. Patients in the IC group will be shown a 10 min video highlighting the negative impact of OSA. While patients in the SC group will only be provided with a pamphlet about OSA and MAA as per standard routine care.
Patients of both the group will be asked to complete questionnaires regarding their personality, socioeconomic status, social support and quality of sleep and life.
Along the course of the treatment, patients in the IC group will be contacted by telephone at 3, 6, 18, and 21 weeks into the treatment to solve any technical problems with the appliance and for verbal encouragement.
Both IC and SC groups will be called for follow-up at 3 and 6 months into the treatment. Data indicating the hours of usage of the MAA will be collected at 3 and 6 months to assess whether patients in the IC group wore the appliance for more hours as compared to those who are in the SC group. Patients will also be required to complete questionnaires at follow-up appointments. Data from the questionnaires will be analyzed to identify the factors influencing patients adherence to MAA.
At the end of follow-up, one-to-one interviews will be conducted with both (n=5-10) compliant (users) and non-compliant (non-users) patients. It will comprise of questions, which will address the following topics:
- Patient's awareness of risks and benefits of OSA
- Barriers and Facilitators of MAA therapy The interviews will be conducted face-to-face and will be recorded using an audio recorder device and transcribed by a third party, Essential Secretary LTD.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Behaviour change Intervention Based on Health Action Process Approach Model, Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
- 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.
Behaviour change Intervention Based on Health Action Process Approach ModelBehavioural
The Behaviour change intervention based on the Health Action Process Approach model entails delivering interventions in a staged manner. Following are the intervention that will be delivered along with the time point of the delivery.
- Health Pamphlet at the initial screening
- Sleep Apnoea video highlighting the negative consequences at the day of the fitting of the appliance
- Counseling involving motivational interviewing for both the participant and the participant's partner at the day of fitting of the appliance and follow up visits.
- Booster phone calls in between the follow-up visits
Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guardDevice
Patients with mild-to-moderate sleep apnoea are treated with Mandibular Advancement Appliances [MAA] also known as Anti-snoring mouth guards or Oral appliances. These are best made to fit and use the teeth to hold them in place during sleep. They work by moving (in a gradual fashion) the bottom jaw forward, opening the airway at the back of the throat.
Both the arms- Intervention arm and Standardized arm will be given the anti-snoring mouth guard. The usage of the device will be measured subjectively by providing a sleep diary to the participants to record the hour of the usage and objectively by downloading the data from a micro sensor chip embedded in the device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Care Group | Experimental | The Intervention care group will receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard. Additionally, they will also receive special support in the form of behaviour change interventions. The behavior change interventions consist of motivational interviewing, will be shown a video highlighting the negative consequences of sleep apnoea.
Booster calls at week 3,6, 18 and 12 for verbal encouragement and to resolve any technical problems with the device.
Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life. Receives: Behavioral: Behaviour change Intervention Based on Health Action Process Approach Model; Device: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard |
| Standardized Care Group | Active comparator | The standardized care group will only receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard along with routine care and will be called for follow up at 3rd and 6th month of treatment to assess their use and to resolve any technical problems with the device.
Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life at the initial visit and subsequent follow-up. Receives: Device: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Measured: 3 months
Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Measured: 6 month
Secondary outcomes (6)
Self-efficacy, risk perception, outcome expectancy
Self-efficacy, risk perception, outcome expectancy will be measured using the Self-efficacy Measure for Sleep Apnoea (SEMSA) questionnaire
Measured: Initial screening, 3 and 6 month
Socio-economic status
Socio-economic Status questionnaire based on National Statistics Socio-Economic Classification.
Measured: Initial Screening
Social support
Social Support Questionnaire
Measured: Initial Screening
Sleep Quality
Sleep Quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: Initial Screening and 6 month
Sleepiness Score: How likely is the participant to fall asleep in certain situations?
Epworth Sleepiness Scale Questionnaire will be used to assess the sleepiness score.
Measured: Initial Screening and 6 month
Health related Quality of Life
EQ-5D questionnaire will be used to measure the quality of life.
Measured: Initial Screening and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start6 Dec 2019
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Queen Mary University of LondonThe 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
- Multicentre Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ama Johal, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092660
- Sponsor's protocol ID
- 262092
- Acronym
- IPOSAT
- Status last verified
- May 2026
- First submitted
- 13 Sep 2019
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tallamraju H, Newton JT, Fleming PS, Johal A. Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial. Trials. 2021 Oct 13;22(1):699. doi: 10.1186/s13063-021-05582-1.
PubMed 34645490
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04092660
- Acronym / sponsor ID
- IPOSAT / 262092
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Sep 2019 (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.
Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care.
The investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index >5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA.
Patients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.
Detailed description
The present study aims to assess whether special support approaches i.e. Interventions influence patients with Obstructive sleep apnoea (OSA), to use the Mandibular Advancement Appliance (MAA) or the anti-snoring mouth guard, more as compared to those who receive standard care.
Factors such as mood, anxiety, stress, depression, socioeconomic status, and social support play an important role in the ability of the patients to make decisions about using the appliance. Thus, the investigators also aim to explore the potential role these factors play in the decision-making process to help future patients make most of their treatments.
Patients meeting the selection criteria will be provided with a patient information leaflet, explaining the whole study. Interested patients will be asked to sign the Informed Consent, after which they will be randomly assigned into two groups- Intervention Care group (IC) and Standardized Care group (SCG).
Patients will be provided with a sleep diary to record their hours of sleep and usage of MAA, which will give a subjective record of the adherence (duration of usage of MAA) and an objective record of the adherence will be collected from a sensor present in the MAA.
At Initial Screening, the patient's age, gender, body mass index (BMI) and neck circumference will be recorded. Patients in the IC group will receive a Health Pamphlet about OSA, specially designed for this study. The IC group's knowledge of OSA will be assessed along with their partner's. Patients in the IC group will be shown a 10 min video highlighting the negative impact of OSA. While patients in the SC group will only be provided with a pamphlet about OSA and MAA as per standard routine care.
Patients of both the group will be asked to complete questionnaires regarding their personality, socioeconomic status, social support and quality of sleep and life.
Along the course of the treatment, patients in the IC group will be contacted by telephone at 3, 6, 18, and 21 weeks into the treatment to solve any technical problems with the appliance and for verbal encouragement.
Both IC and SC groups will be called for follow-up at 3 and 6 months into the treatment. Data indicating the hours of usage of the MAA will be collected at 3 and 6 months to assess whether patients in the IC group wore the appliance for more hours as compared to those who are in the SC group. Patients will also be required to complete questionnaires at follow-up appointments. Data from the questionnaires will be analyzed to identify the factors influencing patients adherence to MAA.
At the end of follow-up, one-to-one interviews will be conducted with both (n=5-10) compliant (users) and non-compliant (non-users) patients. It will comprise of questions, which will address the following topics:
- Patient's awareness of risks and benefits of OSA
- Barriers and Facilitators of MAA therapy The interviews will be conducted face-to-face and will be recorded using an audio recorder device and transcribed by a third party, Essential Secretary LTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Care Group | Experimental | Behavioral: Behaviour change Intervention Based on Health Action Process Approach Model, Device: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guardThe Intervention care group will receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard. Additionally, they will also receive special support in the form of behaviour change interventions. The behavior change interventions consist of motivational interviewing, will be shown a video highlighting the negative consequences of sleep apnoea. Booster calls at week 3,6, 18 and 12 for verbal encouragement and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life. |
| Standardized Care Group | Active comparator | Device: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guardThe standardized care group will only receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard along with routine care and will be called for follow up at 3rd and 6th month of treatment to assess their use and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life at the initial visit and subsequent follow-up. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥ 40 years old)
- Confirmed diagnosis of OSA (AHI ≥ 5)
- Referred for MAA therapy
- Must be able to understand, read and write English; with the assistance of a translator
Key exclusion criteria (5 listed)
- Insufficient teeth for MAA fabrication
- Poor dental and/or periodontal health
- Symptomatic Temporomandibular Disorder (TMD)
- Previously used an MAA
- Patients with Epilepsy
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 |
|---|---|---|
| Behaviour change Intervention Based on Health Action Process Approach ModelThe Behaviour change intervention based on the Health Action Process Approach model entails delivering interventions in a staged manner. Following are the intervention that will be delivered along with the time point of the delivery. 1. Health Pamphlet at the initial screening 2. Sleep Apnoea video highlighting the negative consequences at the day of the fitting of the appliance 3. Counseling involving motivational interviewing for both the participant and the participant's partner at the day of fitting of the appliance and follow up visits. 4. Booster phone calls in between the follow-up visits | Behavioural | Intervention Care Group |
| Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guardPatients with mild-to-moderate sleep apnoea are treated with Mandibular Advancement Appliances [MAA] also known as Anti-snoring mouth guards or Oral appliances. These are best made to fit and use the teeth to hold them in place during sleep. They work by moving (in a gradual fashion) the bottom jaw forward, opening the airway at the back of the throat. Both the arms- Intervention arm and Standardized arm will be given the anti-snoring mouth guard. The usage of the device will be measured subjectively by providing a sleep diary to the participants to record the hour of the usage and objectively by downloading the data from a micro sensor chip embedded in the device. | Device | Intervention Care Group, Standardized Care Group |
Primary outcome
Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
Time frame: 3 months
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard
Time frame: 6 month
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
6 secondary outcomes
Self-efficacy, risk perception, outcome expectancy
Time frame: Initial screening, 3 and 6 month
Socio-economic status
Time frame: Initial Screening
Social support
Time frame: Initial Screening
Sleep Quality
Time frame: Initial Screening and 6 month
Sleepiness Score: How likely is the participant to fall asleep in certain situations?
Time frame: Initial Screening and 6 month
Health related Quality of Life
Time frame: Initial Screening and 6 month
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 6 May 2026.
- Derived from this study: PubMed 34645490Tallamraju H, Newton JT, Fleming PS, Johal A. Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial. Trials. 2021 Oct 13;22(1):699. doi: 10.1186/s13063-021-05582-1.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Ama Johal study chair
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change Intervention Based on Health Action Process Approach Model and Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard in people with Obstructive Sleep Apnea, run by Queen Mary University of London 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 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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?
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 Ama Johal (0207 377 7686, a.s.johal@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04092660, which also lists 1 linked publication.
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 May 2026.