Obstructive Sleep ApneaPhase 4DISERTNCT03892122
Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy
A Phase 4 study testing Propofol Fresenius and Dexmedetomidine in people with Obstructive Sleep Apnea, run by Ospedale Monsignor R. Dimiccoli, Barletta at 1 site in Italy.
Trial summary
Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Propofol Fresenius and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2019to Sep 2020
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea-Hypopnea Index (AHI) of 15-30.
- Men and women, age 18-65 years, Body Mass Index (BMI) < 35 Kg/m2,
- Awake oxygen saturation > 95%
- Able to read and sign the consent form
Who cannot join
- Chronic Obstructive Pulmonary Disease (COPD)
- Liver disease (Child Pugh 1-3)
- History of chronic use of sedatives, narcotics, alcohol or illicit drugs,
- History of 1st and 2nd degree heart block (not paced),
- Left Ventricular Ejection Fraction (LVEF) < 50%,
- Allergy to propofol or Dexmedetomidine,
- OSHAS (Obstructive sleep apnea/hypopnea syndrome) surgical failure patients
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O.C. Otorinolaringoiatria Ospedale Di Barletta
Barletta, BAT, 76121
ILARIA ALICINO, MD, 3334080997, i.alicino@libero.it
About this study
Official title: Randomised Monocentric -Controlled Study to Evaluate the Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Routinely Diagnostic Examination: Drug Induced Sleep Endoscopy
Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy (DISE) is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.
Read the detailed description
Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.
It's a Randomized Controlled study. 28 participants will be enrolled and randomized in two groups: in the first group the sedation state will be performed with Propofol, while in the second group will be used Dexmedetomidine for allow sedation state. The study will be evaluate the different hemodynamic and respiratory changes during sedation in these two different groups and differences in obstructive endoscopic anatomical patterns. This will be the first study in whic Dexmedetomidine and Propofol will be compared according to European DISE Recommendation published in august 2018 (references)
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Propofol Fresenius, Dexmedetomidine
- Keywords
- Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol
- 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.
Propofol FreseniusDrug
Propofol will be infused with TCI (Target Controlled Infusion) pump. TCI system has been developed to provide improved convenience and control during intravenous anaesthesia. The basic principle is that the anesthetist sets and adjusts the target blood concentration- and depth of anesthesia-as required on clinical grounds.
Infusion rates are altered automatically according to a validated pharmacokinetic model. TCI technology uses different pharmacokinetic modeling to control the infusion rate of the pump, which allows for a direct control of the sedative agent brain concentration rather than its blood concentration. (de vito 2017) The development of target-controlled infusion (TCI) technology has increased the number of indications for propofol sedation in clinical practice. Furthermore, several studies have demonstrated that propofol-based TCI allows for the accurate control of sedation during DISE and results in an authentic reproduction of the sleep process.
DexmedetomidineDrug
is a selective alpha-2 adrenergic receptor agonist, which seems to act on the locus coeruleus (LC) or to the preoptic hypothalamus to decrease wakefulness, with almost no effect on respiratory depression. Dexmedetomidine exerts its hypnotic action through activation of central pre- and postsyn¬aptic alpha2-receptors in the locus coeruleus, thereby inducting a state of unconsciousness similar to natural sleep, with the unique as¬pect that patients remain easily arousable and cooperative. Comparing with propofol, dexmedetomidine provides a state of sedation closer to natural sleep and lesser upper airways muscular relaxing effect, even at the increased anesthetic dosage Otherwise, Dexmedetomidine is characterized by a slightly longer onset of action (5-10 minutes), and patients take longer timing to recover..The sedative action of Dexmedetomidine can be reached by means of infusion technique (starting dose: 1 μg/kg over 10 minutes; maintenance infusion rate: 0,7 μg/kg/h).
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Other | Sleep endoscopy will be performed by a Target Controlled Infusion system (BRAUN perfusion system) using Schneider model in effect-site (cerebral) targeted infusion 50-ml prefilled syringe of 1% propofol. Schneider system is a complex pharmacokinetic/pharmacodynamic (PK/PD) model that allows to obtain different rates of drug from the values of age, height, weight and lean body mass of the patient
. The starting dose of propofol will be 2-2,5 mcg ml-1 and increments of 0.2 mcg ml-1 took place when the new cerebral concentration of propofol will be reached, and never before 5 minutes. In this way, the investigators will be realized a slow technique of TCI propofol infusion according to European working group Receives: Drug: Propofol Fresenius |
| Dexmedetomidine group | Other | For the D-DISE group, dexmedetomidine will be administered with an IV infusion at 1 mcg/kg over 10 minutes, followed by a maintenance rate of 0,7 mcg/kg/h. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation variation during DISE
every 5 minute will be recorded this variation and for all exam duration
Measured: during DISE time (until 40 minutes)
hert rate variation during DISE
every 5 minute will be recorded this variation and for all exam duration
Measured: during DISE time (until 40 minutes)
systolic and diastolic blood pressure variation during DISE
every 5 minute will be recorded this variation and for all exam duration
Measured: during DISE time (until 40 minutes)
adverse events during DISE
Number of Participants with arterial hypotension, hypertension; number of desaturation episodes below 60%; rate of patients with heart rate below 50 beats per minute.
Measured: during DISE time (until 40 minutes)
Secondary outcomes (1)
pharyngeal and laryngeal patterns during DISE
pharyngeal and laryngeal patterns observed during DISE will be compared with patterns observed during awake endoscopic evaluation, the vote classification will be used
Measured: during DISE time (until 40 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start22 Mar 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it's a randomized controlled single center study
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Monsignor R. Dimiccoli, Barletta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barbara, Ospedale Monsignor R. Dimiccoli, Barletta
- Investigators
- Michele Barbara, MD, Principal investigator, Otorhinolaryngology Department of Barletta's hospitalFrancesco Barbara, MD, Study chair, Otorhinolaryngology department of " Policlinico di Bari"Ilaria Alicino, MD, Study chair, Anesthesia Department of Barletta's hospitalValentina Dibenedetto, MD, Study chair, Otorhinolaryngology Department of Barletta's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892122
- Sponsor's protocol ID
- 01-19
- Other IDs
- 2019-001429-28, 2019
- Acronym
- DISERT
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padiyara TV, Bansal S, Jain D, Arora S, Gandhi K. Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial. Laryngoscope. 2020 Jan;130(1):257-262. doi: 10.1002/lary.27903. Epub 2019 Mar 1.
PubMed 30821349Zhao LL, Liu H, Zhang YY, Wei JQ, Han Y, Han L, Yang JP. A Comparative Study on Efficacy and Safety of Propofol versus Dexmedetomidine in Sleep Apnea Patients undergoing Drug-Induced Sleep Endoscopy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Biomed Res Int. 2018 Nov 1;2018:8696510. doi: 10.1155/2018/8696510. eCollection 2018.
PubMed 30515416Viana A, Zhao C, Rosa T, Couto A, Neves DD, Araujo-Melo MH, Capasso R. The Effect of Sedating Agents on Drug-Induced Sleep Endoscopy Findings. Laryngoscope. 2019 Feb;129(2):506-513. doi: 10.1002/lary.27298. Epub 2018 Sep 7.
PubMed 30194726De Vito A, Carrasco Llatas M, Ravesloot MJ, Kotecha B, De Vries N, Hamans E, Maurer J, Bosi M, Blumen M, Heiser C, Herzog M, Montevecchi F, Corso RM, Braghiroli A, Gobbi R, Vroegop A, Vonk PE, Hohenhorst W, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sleep endoscopy: 2017 Update. Clin Otolaryngol. 2018 Dec;43(6):1541-1552. doi: 10.1111/coa.13213. Epub 2018 Sep 30.
PubMed 30133943De Vito A, Agnoletti V, Zani G, Corso RM, D'Agostino G, Firinu E, Marchi C, Hsu YS, Maitan S, Vicini C. The importance of drug-induced sedation endoscopy (D.I.S.E.) techniques in surgical decision making: conventional versus target controlled infusion techniques-a prospective randomized controlled study and a retrospective surgical outcomes analysis. Eur Arch Otorhinolaryngol. 2017 May;274(5):2307-2317. doi: 10.1007/s00405-016-4447-x. Epub 2017 Feb 17.
PubMed 28213776De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.
PubMed 20811901
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Monocentric -Controlled Study to Evaluate the Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Routinely Diagnostic Examination: Drug Induced Sleep Endoscopy
- ClinicalTrials.gov ID
- NCT03892122
- Acronym / sponsor ID
- DISERT / 01-19
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ospedale Monsignor R. Dimiccoli, BarlettaUniversity, hospital or other
- Study start
- 22 Mar 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Mar 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 Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy (DISE) is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.
Detailed description
Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.
It's a Randomized Controlled study. 28 participants will be enrolled and randomized in two groups: in the first group the sedation state will be performed with Propofol, while in the second group will be used Dexmedetomidine for allow sedation state. The study will be evaluate the different hemodynamic and respiratory changes during sedation in these two different groups and differences in obstructive endoscopic anatomical patterns. This will be the first study in whic Dexmedetomidine and Propofol will be compared according to European DISE Recommendation published in august 2018 (references)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- it's a randomized controlled single center study
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Other | Drug: Propofol FreseniusSleep endoscopy will be performed by a Target Controlled Infusion system (BRAUN perfusion system) using Schneider model in effect-site (cerebral) targeted infusion 50-ml prefilled syringe of 1% propofol. Schneider system is a complex pharmacokinetic/pharmacodynamic (PK/PD) model that allows to obtain different rates of drug from the values of age, height, weight and lean body mass of the patient . The starting dose of propofol will be 2-2,5 mcg ml-1 and increments of 0.2 mcg ml-1 took place when the new cerebral concentration of propofol will be reached, and never before 5 minutes. In this way, the investigators will be realized a slow technique of TCI propofol infusion according to European working group |
| Dexmedetomidine group | Other | Drug: DexmedetomidineFor the D-DISE group, dexmedetomidine will be administered with an IV infusion at 1 mcg/kg over 10 minutes, followed by a maintenance rate of 0,7 mcg/kg/h. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Apnea-Hypopnea Index (AHI) of 15-30.
- Men and women, age 18-65 years, Body Mass Index (BMI) < 35 Kg/m2,
- Awake oxygen saturation > 95%
- Able to read and sign the consent form
Key exclusion criteria (8 listed)
- Chronic Obstructive Pulmonary Disease (COPD)
- Liver disease (Child Pugh 1-3)
- History of chronic use of sedatives, narcotics, alcohol or illicit drugs,
- History of 1st and 2nd degree heart block (not paced),
- Left Ventricular Ejection Fraction (LVEF) < 50%,
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 |
|---|---|---|
| Propofol FreseniusPropofol will be infused with TCI (Target Controlled Infusion) pump. TCI system has been developed to provide improved convenience and control during intravenous anaesthesia. The basic principle is that the anesthetist sets and adjusts the target blood concentration- and depth of anesthesia-as required on clinical grounds. Infusion rates are altered automatically according to a validated pharmacokinetic model. TCI technology uses different pharmacokinetic modeling to control the infusion rate of the pump, which allows for a direct control of the sedative agent brain concentration rather than its blood concentration. (de vito 2017) The development of target-controlled infusion (TCI) technology has increased the number of indications for propofol sedation in clinical practice. Furthermore, several studies have demonstrated that propofol-based TCI allows for the accurate control of sedation during DISE and results in an authentic reproduction of the sleep process. | Drug | Propofol group |
| Dexmedetomidineis a selective alpha-2 adrenergic receptor agonist, which seems to act on the locus coeruleus (LC) or to the preoptic hypothalamus to decrease wakefulness, with almost no effect on respiratory depression. Dexmedetomidine exerts its hypnotic action through activation of central pre- and postsyn¬aptic alpha2-receptors in the locus coeruleus, thereby inducting a state of unconsciousness similar to natural sleep, with the unique as¬pect that patients remain easily arousable and cooperative. Comparing with propofol, dexmedetomidine provides a state of sedation closer to natural sleep and lesser upper airways muscular relaxing effect, even at the increased anesthetic dosage Otherwise, Dexmedetomidine is characterized by a slightly longer onset of action (5-10 minutes), and patients take longer timing to recover..The sedative action of Dexmedetomidine can be reached by means of infusion technique (starting dose: 1 μg/kg over 10 minutes; maintenance infusion rate: 0,7 μg/kg/h). | Drug | Dexmedetomidine group |
Primary outcome
oxygen saturation variation during DISE
Time frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
hert rate variation during DISE
Time frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
systolic and diastolic blood pressure variation during DISE
Time frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
adverse events during DISE
Time frame: during DISE time (until 40 minutes)
Number of Participants with arterial hypotension, hypertension; number of desaturation episodes below 60%; rate of patients with heart rate below 50 beats per minute.
1 secondary outcome
pharyngeal and laryngeal patterns during DISE
Time frame: during DISE time (until 40 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Background: PubMed 30821349Padiyara TV, Bansal S, Jain D, Arora S, Gandhi K. Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial. Laryngoscope. 2020 Jan;130(1):257-262. doi: 10.1002/lary.27903. Epub 2019 Mar 1.
- Background: PubMed 30515416Zhao LL, Liu H, Zhang YY, Wei JQ, Han Y, Han L, Yang JP. A Comparative Study on Efficacy and Safety of Propofol versus Dexmedetomidine in Sleep Apnea Patients undergoing Drug-Induced Sleep Endoscopy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Biomed Res Int. 2018 Nov 1;2018:8696510. doi: 10.1155/2018/8696510. eCollection 2018.
- Background: PubMed 30194726Viana A, Zhao C, Rosa T, Couto A, Neves DD, Araujo-Melo MH, Capasso R. The Effect of Sedating Agents on Drug-Induced Sleep Endoscopy Findings. Laryngoscope. 2019 Feb;129(2):506-513. doi: 10.1002/lary.27298. Epub 2018 Sep 7.
- Background: PubMed 30133943De Vito A, Carrasco Llatas M, Ravesloot MJ, Kotecha B, De Vries N, Hamans E, Maurer J, Bosi M, Blumen M, Heiser C, Herzog M, Montevecchi F, Corso RM, Braghiroli A, Gobbi R, Vroegop A, Vonk PE, Hohenhorst W, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sleep endoscopy: 2017 Update. Clin Otolaryngol. 2018 Dec;43(6):1541-1552. doi: 10.1111/coa.13213. Epub 2018 Sep 30.
- Background: PubMed 28213776De Vito A, Agnoletti V, Zani G, Corso RM, D'Agostino G, Firinu E, Marchi C, Hsu YS, Maitan S, Vicini C. The importance of drug-induced sedation endoscopy (D.I.S.E.) techniques in surgical decision making: conventional versus target controlled infusion techniques-a prospective randomized controlled study and a retrospective surgical outcomes analysis. Eur Arch Otorhinolaryngol. 2017 May;274(5):2307-2317. doi: 10.1007/s00405-016-4447-x. Epub 2017 Feb 17.
- Background: PubMed 20811901De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.
- Individual participant dataSharing planned: No
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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.
Michele Barbara, MD principal investigator
Otorhinolaryngology Department of Barletta's hospital
Francesco Barbara, MD study chair
Otorhinolaryngology department of " Policlinico di Bari"
Ilaria Alicino, MD study chair
Anesthesia Department of Barletta's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol Fresenius and Dexmedetomidine in people with Obstructive Sleep Apnea, run by Ospedale Monsignor R. Dimiccoli, Barletta at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 29 Mar 2019. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Alicino, MD (3334080997, i.alicino@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation variation during DISE (time frame: during DISE time (until 40 minutes)). The study lists 4 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 NCT03892122, 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 29 Mar 2019.