Hypertension,EssentialCRESCENTNCT04119999
A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling
A study testing Mandibular Advancement Device and Continuous Positive Airway Pressure in people with Hypertension,Essential and Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
Trial summary
The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension,Essential, Obstructive Sleep Apnea
- What is being tested?
- Mandibular Advancement Device and Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Oct 2019to 15 Feb 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 40 years
- Chinese (based on the Identity Card or other Identity Document if the subject is a non-Singapore citizen or permanent resident)
- Physician diagnosed essential hypertension, on at least 1 medication for BP control
- High cardiovascular risk, as defined by one or more of the following: (a) diabetes mellitus, (b) stroke, (c) significant coronary artery disease (at least one stenosis of >50% diameter in at least one major epicardial artery), (d) chronic kidney disease, excluding polycystic kidney disease, with an estimated glomerular filtration rate of <60 ml/min/1.73m2, or (e) age of 75 years or older.
Who cannot join
- Known OSA on treatment
- Cheyne-Stokes breathing or predominantly central sleep apnea (>50%)
- Known secondary hypertension: from renal (renal artery stenosis, chronic renal failure); endocrine (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism) or cardiac causes (aortic coarctation)
- Contraindications to CMR: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and pregnant women
- Contraindications to MAD: <6 to 10 teeth in each arch, inability to advance the mandible and open the jaw widely, pre-existing temporomandibular joint problems, severe bruxism
- Limited life expectancy (< 1 year)
- Hypertensive crisis, acute coronary syndromes or acute heart failure in the past 30 days
- Known AF (not suitable for CMR and affects remodelling analysis)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Apart from improving quality of-life, an effective OSA treatment could improve cardiovascular risk partly through blood pressure reduction, particularly in patients with high cardiovascular risk in whom blood pressure control is often suboptimal. Although CPAP is useful, the high non-acceptance and non-adherence preclude its widespread use.
East Asians have a restrictive craniofacial phenotype that predisposes them to OSA and the associated cardiovascular stress. CPAP, while considered the first-line therapy for OSA, has failed to improve cardiovascular outcomes in randomized trials till date because it is poorly tolerated. MADs are oral appliances that correct the restrictive craniofacial phenotype present in East Asians by protruding the lower jaw to reduce upper airway collapsibility. MADs are better tolerated than CPAP, and this may be an important determinant of the overall effectiveness in treating OSA, and thus ameliorating the downstream adverse health outcomes. We hypothesize that MADs are non-inferior to CPAP in treating OSA and reducing cardiovascular risk by blood pressure reduction in East Asians.
We will recruit East Asian subjects with hypertension and high cardiovascular risk for polysomnography. Patients diagnosed with OSA (n=220) will be randomized to MAD or CPAP groups in a 1:1 ratio for a treatment duration of 6 months. The primary endpoint is the 24-hour mean blood pressure as determined by ambulatory monitoring. The secondary endpoints include sleep-time systolic BP, target blood pressure, cardiovascular biomarkers, and myocardial remodeling. Association between OSA and silent paroxysmal atrial fibrillation will also be determined. If MADs are shown to be effective, the next step is to evaluate our novel device- drug-eluting MAD that the team is developing.
- Conditions
- Hypertension,Essential, Obstructive Sleep Apnea
- Being tested
- Mandibular Advancement Device, Continuous Positive Airway Pressure
- Keywords
- sleep, remodeling, blood pressure, trial
- Medical subject headings
- Essential Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DeviceDevice
Mandibular advancement device (MAD) has been a novel method in the management of snoring and OSA. For mild to moderate sleep apnea, MADs have been a boon. A guideline published by American Academy of Sleep Medicine stated that MAD was indicated as first-line therapy for mild OSA and a second-line therapy for moderate to severe OSA
Continuous Positive Airway PressureDevice
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people with OSA
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | Continuous Positive Airway Pressure Receives: Device: Continuous Positive Airway Pressure |
| MAD | Experimental | Mandibular Advancement Device Receives: Device: Mandibular Advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mean BP (24MBP)
Difference in 24-hour mean BP (24MBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Measured: 6 months
Secondary outcomes (17)
24-hour systolic BP (24SBP)
Difference in 24-hour systolic BP (24SBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Measured: 6 months and 12 months
24-hour pulse pressure (24PP)
Difference in 24-hour pulse pressure (24PP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Measured: 6 months and 12 months
Nocturnal dipping
Difference in prevalence of nocturnal dipping between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Measured: 6 months and 12 months
Ectopic beat
Difference in prevalence of ectopic beats between the patients in the MAD and CPAP groups as determined by continuous ECG monitoring
Measured: 12 months
Myocardial remodeling
Difference in LV and LA dimensions between the patients in the MAD and CPAP groups as determined by cardiac MRI
Measured: 12 months
Epworth Sleepiness Scale (ESS) score
Difference in change in ESS score between the MAD and CPAP groups
Measured: 6 months and 12 months
Sleep Apnea Quality of Life Index (SAQLI)
Difference in change in SAQLI score between the MAD and CPAP groups
Measured: 6 months and 12 months
Functional Outcome of Sleep Questionnaire (FOSQ)
Difference in change in SAQLI score between the MAD and CPAP groups
Measured: 6 months and 12 months
36-Item Short Form Health Survey (SF-36)
Difference in change in SF-36 score between the MAD and CPAP groups
Measured: 6 months and 12 months
EuroQol 5Q (EQ5D)
Difference in change in EQ5D score between the MAD and CPAP groups
Measured: 6 months and 12 months
Daytime systolic BP
Difference in change in daytime systolic BP between the patients in the MAD and CPAP
Measured: 6 months and 12 months
Nighttime systolic BP
Difference in change in nighttime systolic BP between the patients in the MAD and CPAP
Measured: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<130 mmHg
Difference in percentage of patients with 24-hour systolic BP<130 mmHg in the MAD and CPAP groups
Measured: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<120 mmHg
Difference in percentage of patients with 24-hour systolic BP<120 mmHg in the MAD and CPAP groups
Measured: 6 months and 12 months
NT-proBNP
Change in the plasma level of NT-proBNP from baseline to 6-month follow-up
Measured: 6 months and 12 months
High sensitivity troponin
Change in the plasma level of high sensitivity troponin from baseline to 6-month follow-up
Measured: 6 months and 12 months
High sensitive C-reactive protein
Change in the plasma level of high sensitive C-reactive protein from baseline to 6-month follow-up
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start16 Oct 2019
- Primary completion31 Aug 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University Hospital, Singapore, National Heart Centre Singapore
- Responsible party
- Principal investigator, Chi-Hang Lee, National University of Singapore
- Investigators
- Chi-Hang Lee, MD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119999
- Sponsor's protocol ID
- Senior CSA
- Acronym
- CRESCENT
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data generated by the CRESCENT trial will be made available as soon as possible upon reasonable request, wherever legally and ethically possible.
Publications
Ou YH, Colpani JT, Cheong CS, Loke W, Thant AT, Shih EC, Lee F, Chan SP, Sia CH, Koo CY, Teo YH, Chan J, Wong S, Chua A, Khoo CM, Kong WK, Chin CW, Kojodjojo P, Wong PE, Hausenloy D, Chan MY, Richards AM, Cistulli PA, Lee CH. Treatment of OSA using mandibular advancement versus CPAP in improving cardiovascular health. Am J Med. 2026 Apr 19:S0002-9343(26)00293-7. doi: 10.1016/j.amjmed.2026.04.008. Online ahead of print.
PubMed 42013991Colpani JT, Ou YH, Kosasih AM, Lee FKF, Chan SP, Tan HH, Wong RCW, Chin CW, Cistulli PA, Lee CH. Mandibular Advancement Device versus CPAP in Severe Obstructive Sleep Apnea. J Dent Res. 2026 Jan;105(1):112-119. doi: 10.1177/00220345251361796. Epub 2025 Sep 1.
PubMed 40888163Colpani JT, Ou YH, Thakumar AV, Cheong CS, Loke W, Sia CH, Teo YH, Chan SP, Chin CW, Kojodjojo P, Chan MY, Cistulli PA, Luo N, Lee CH. Patient-reported quality of life outcomes with mandibular advancement versus continuous positive airway pressure: insights from the CRESCENT trial. Sleep. 2025 Nov 10;48(11):zsaf022. doi: 10.1093/sleep/zsaf022.
PubMed 39887015Ou YH, Colpani JT, Cheong CS, Loke W, Thant AT, Shih EC, Lee F, Chan SP, Sia CH, Koo CY, Wong S, Chua A, Khoo CM, Kong W, Chin CW, Kojodjojo P, Wong PE, Chan MY, Richards AM, Cistulli PA, Lee CH. Mandibular Advancement vs CPAP for Blood Pressure Reduction in Patients With Obstructive Sleep Apnea. J Am Coll Cardiol. 2024 May 7;83(18):1760-1772. doi: 10.1016/j.jacc.2024.03.359. Epub 2024 Apr 6.
PubMed 38588926Ou YH, Colpani JT, Chan SP, Loke W, Cheong CS, Kong W, Chin CW, Kojodjojo P, Wong P, Cistulli P, Lee CH. Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol. BMJ Open. 2023 May 31;13(5):e072853. doi: 10.1136/bmjopen-2023-072853.
PubMed 37258080
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling
- ClinicalTrials.gov ID
- NCT04119999
- Acronym / sponsor ID
- CRESCENT / Senior CSA
- Conditions
- Hypertension,Essential, Obstructive Sleep Apnea
- Keywords
- sleep, remodeling, blood pressure, trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University Hospital, Singapore, National Heart Centre Singapore
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 9 Oct 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.
The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Apart from improving quality of-life, an effective OSA treatment could improve cardiovascular risk partly through blood pressure reduction, particularly in patients with high cardiovascular risk in whom blood pressure control is often suboptimal. Although CPAP is useful, the high non-acceptance and non-adherence preclude its widespread use.
East Asians have a restrictive craniofacial phenotype that predisposes them to OSA and the associated cardiovascular stress. CPAP, while considered the first-line therapy for OSA, has failed to improve cardiovascular outcomes in randomized trials till date because it is poorly tolerated. MADs are oral appliances that correct the restrictive craniofacial phenotype present in East Asians by protruding the lower jaw to reduce upper airway collapsibility. MADs are better tolerated than CPAP, and this may be an important determinant of the overall effectiveness in treating OSA, and thus ameliorating the downstream adverse health outcomes. We hypothesize that MADs are non-inferior to CPAP in treating OSA and reducing cardiovascular risk by blood pressure reduction in East Asians.
We will recruit East Asian subjects with hypertension and high cardiovascular risk for polysomnography. Patients diagnosed with OSA (n=220) will be randomized to MAD or CPAP groups in a 1:1 ratio for a treatment duration of 6 months. The primary endpoint is the 24-hour mean blood pressure as determined by ambulatory monitoring. The secondary endpoints include sleep-time systolic BP, target blood pressure, cardiovascular biomarkers, and myocardial remodeling. Association between OSA and silent paroxysmal atrial fibrillation will also be determined. If MADs are shown to be effective, the next step is to evaluate our novel device- drug-eluting MAD that the team is developing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: Continuous Positive Airway PressureContinuous Positive Airway Pressure |
| MAD | Experimental | Device: Mandibular Advancement DeviceMandibular Advancement Device |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of at least 40 years
- Chinese (based on the Identity Card or other Identity Document if the subject is a non-Singapore citizen or permanent resident)
- Physician diagnosed essential hypertension, on at least 1 medication for BP control
- High cardiovascular risk, as defined by one or more of the following: (a) diabetes mellitus, (b) stroke, (c) significant coronary artery disease (at least one stenosis of >50% diameter in at least one major epicardial artery), (d) chronic kidney disease, excluding polycystic kidney disease, with an estimated glomerular filtration rate of <60 ml/min/1.73m2, or (e) age of 75 years or older.
Key exclusion criteria (8 listed)
- Known OSA on treatment
- Cheyne-Stokes breathing or predominantly central sleep apnea (>50%)
- Known secondary hypertension: from renal (renal artery stenosis, chronic renal failure); endocrine (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism) or cardiac causes (aortic coarctation)
- Contraindications to CMR: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and pregnant women
- Contraindications to MAD: <6 to 10 teeth in each arch, inability to advance the mandible and open the jaw widely, pre-existing temporomandibular joint problems, severe bruxism
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 |
|---|---|---|
| Mandibular Advancement DeviceMandibular advancement device (MAD) has been a novel method in the management of snoring and OSA. For mild to moderate sleep apnea, MADs have been a boon. A guideline published by American Academy of Sleep Medicine stated that MAD was indicated as first-line therapy for mild OSA and a second-line therapy for moderate to severe OSA | Device | MAD |
| Continuous Positive Airway PressureContinuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people with OSA | Device | CPAP |
Primary outcome
24-hour mean BP (24MBP)
Time frame: 6 months
Difference in 24-hour mean BP (24MBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
17 secondary outcomes
24-hour systolic BP (24SBP)
Time frame: 6 months and 12 months
24-hour pulse pressure (24PP)
Time frame: 6 months and 12 months
Nocturnal dipping
Time frame: 6 months and 12 months
Ectopic beat
Time frame: 12 months
Myocardial remodeling
Time frame: 12 months
Epworth Sleepiness Scale (ESS) score
Time frame: 6 months and 12 months
Sleep Apnea Quality of Life Index (SAQLI)
Time frame: 6 months and 12 months
Functional Outcome of Sleep Questionnaire (FOSQ)
Time frame: 6 months and 12 months
36-Item Short Form Health Survey (SF-36)
Time frame: 6 months and 12 months
EuroQol 5Q (EQ5D)
Time frame: 6 months and 12 months
Daytime systolic BP
Time frame: 6 months and 12 months
Nighttime systolic BP
Time frame: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<130 mmHg
Time frame: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<120 mmHg
Time frame: 6 months and 12 months
NT-proBNP
Time frame: 6 months and 12 months
High sensitivity troponin
Time frame: 6 months and 12 months
High sensitive C-reactive protein
Time frame: 6 months and 12 months
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 20 Feb 2024.
- Derived from this study: PubMed 42013991Ou YH, Colpani JT, Cheong CS, Loke W, Thant AT, Shih EC, Lee F, Chan SP, Sia CH, Koo CY, Teo YH, Chan J, Wong S, Chua A, Khoo CM, Kong WK, Chin CW, Kojodjojo P, Wong PE, Hausenloy D, Chan MY, Richards AM, Cistulli PA, Lee CH. Treatment of OSA using mandibular advancement versus CPAP in improving cardiovascular health. Am J Med. 2026 Apr 19:S0002-9343(26)00293-7. doi: 10.1016/j.amjmed.2026.04.008. Online ahead of print.
- Derived from this study: PubMed 40888163Colpani JT, Ou YH, Kosasih AM, Lee FKF, Chan SP, Tan HH, Wong RCW, Chin CW, Cistulli PA, Lee CH. Mandibular Advancement Device versus CPAP in Severe Obstructive Sleep Apnea. J Dent Res. 2026 Jan;105(1):112-119. doi: 10.1177/00220345251361796. Epub 2025 Sep 1.
- Derived from this study: PubMed 39887015Colpani JT, Ou YH, Thakumar AV, Cheong CS, Loke W, Sia CH, Teo YH, Chan SP, Chin CW, Kojodjojo P, Chan MY, Cistulli PA, Luo N, Lee CH. Patient-reported quality of life outcomes with mandibular advancement versus continuous positive airway pressure: insights from the CRESCENT trial. Sleep. 2025 Nov 10;48(11):zsaf022. doi: 10.1093/sleep/zsaf022.
- Derived from this study: PubMed 38588926Ou YH, Colpani JT, Cheong CS, Loke W, Thant AT, Shih EC, Lee F, Chan SP, Sia CH, Koo CY, Wong S, Chua A, Khoo CM, Kong W, Chin CW, Kojodjojo P, Wong PE, Chan MY, Richards AM, Cistulli PA, Lee CH. Mandibular Advancement vs CPAP for Blood Pressure Reduction in Patients With Obstructive Sleep Apnea. J Am Coll Cardiol. 2024 May 7;83(18):1760-1772. doi: 10.1016/j.jacc.2024.03.359. Epub 2024 Apr 6.
- Derived from this study: PubMed 37258080Ou YH, Colpani JT, Chan SP, Loke W, Cheong CS, Kong W, Chin CW, Kojodjojo P, Wong P, Cistulli P, Lee CH. Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol. BMJ Open. 2023 May 31;13(5):e072853. doi: 10.1136/bmjopen-2023-072853.
- Individual participant dataSharing planned: Undecided. The individual participant data generated by the CRESCENT trial will be made available as soon as possible upon reasonable request, wherever legally and ethically possible.
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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.
Chi-Hang Lee, MD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Advancement Device and Continuous Positive Airway Pressure in people with Hypertension,Essential and Obstructive Sleep Apnea, run by National University of Singapore at 1 site in Singapore.
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 8 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 20 Feb 2024. 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 Singapore. 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?
24-hour mean BP (24MBP) (time frame: 6 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 NCT04119999, which also lists 5 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 20 Feb 2024.