Sleep Disordered BreathingPhase 2/3NCT06756971
DISE in Pediatric Sleep Disordered Breathing
A Phase 2/3 study testing Propofol and Dexmedetomidine in people with Sleep Disordered Breathing and Drug Induced Sleep Disorder, run by University of Iowa.
Trial summary
Adenotonsillar hypertrophy is the most common reason for children to have sleep disordered breathing (SDB). Even though adenotonsillectomy improves sleep apnea in children, 20-40% of children will still have persistent SDB. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Sleep Disordered Breathing, Drug Induced Sleep Disorder
- What is being tested?
- Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to Nov 2023
- Phase
- Phase 2/3
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 1 month-18 years of age
- Clinical diagnosis of sleep disordered breathing (SDB) either based on a Pediatric sleep questionnaire (>33% on modified Pediatric Sleep Questionnaire (PSQ)) or Sleep study
- Subject is deemed a surgical candidate for undergoing DISE, adenotonsillectomy or DISE directed surgery
Who cannot join
- Adult patients
- Hypersensitivity to propofol or dexmedetomidine or any of their components,
- Allergies to eggs, egg products, soybeans, or soy products,
- Congenital cardiac disease, cardiac conduction system pathology, and increased pulmonary artery pressure or decreased cardiac output (e.g., right-sided heart failure, septic shock).
- Children who are receiving medicines with rate-slowing action on the atrioventricular node (eg, digoxin, nifedipine)
About this study
Official title: Comparison Between Propofol and Dexmedetomidine as Anesthetic Protocols for Drug Induced Sleep Endoscopy (DISE) in Pediatric Patients With Sleep Disordered Breathing: A Prospective Randomized Controlled Trial
Adenotonsillar hypertrophy is the most common reason for children to have sleep disordered breathing (SDB). Even though adenotonsillectomy improves sleep apnea in children, 20-40% of children will still have persistent SDB. Drug Induced Sleep Endoscopy (DISE) is a tool that dynamically evaluates the upper airway during simulated sleep. It identifies sites of upper airway obstruction and/or collapse. It is used to predict which children will get better if their tonsils and adenoids are removed, and which children have other reasons for SDB. DISE is done during a state of simulated sleep. Different anesthetic medications are currently being used. However, there is no identified ideal anesthetic medication to simulate natural sleep. Propofol and Dexmedetomidine are the most frequently used, either alone or in combination with other medications. The aim is to perform a head-to-head study comparing those 2 commonly used regimens. The investigator would like to learn how the anesthetic medication affects performing the procedure and how well our patients tolerate it. This helps us identify an ideal regimen that can be a standardized DISE protocol in the pediatric population in the future. Our objective is to determine which anesthetic regimen, Dexmedetomidine or Propofol, is safer and more efficacious. This will be a randomized controlled trial at the University of Iowa Stead Family Children's Hospital. Children with sleep disordered breathing will undergo DISE and subsequent surgical procedure based on the level of obstruction found during DISE. Via randomization the child will be preselected to have a specific anesthetic for the procedure, either Dexmedetomidine or Propofol. The investigator will record information related to the medications used, the vital signs, the ability to perform DISE fully, the findings seen on DISE and the surgery performed. Consent will be obtained from the legal guardian or parent with legal authority to consent.
Read the detailed description
Drug-induced sleep endoscopy (DISE) in children has gained popularity in the past 10 years. Its most valuable use is in patients with sleep disordered breathing (SDB). DISE is capable of identifying dynamic sites of upper airway obstruction and or collapse during sleep, beyond the tonsils and adenoids. It is also capable of identifying the degree of dynamic obstruction caused by different anatomical structures. Currently, pediatric patients with SDB diagnosed either clinically with the help of a validated sleep questionnaire or on the basis of sleep study and undergo surgery depending on the level of the obstruction. The surgery most commonly performed is adenotonsillectomy. In order to diagnose the level of obstruction DISE is performed. Currently, there is a lack in consensus regarding the ideal anesthetic regimen to simulate natural sleep and poor agreement regarding DISE anesthetic protocols among experts. An ideal agent would provide sufficient analgesia under near-physiologic settings and prevent substantial airway collapse, respiratory depression, and cardiovascular effects. It should have a predictable period of action and a smooth emergence. Multiple anesthetic regimens have been used for DISE. This includes inhalation anesthesia such as Sevoflurane, total intravenous anesthesia (TIVA) such as Propofol alone or with Remifentanil, and Dexmedetomidine alone or with Ketamine. Propofol and Dexmedetomidine are the most frequently used regimens, either alone or in combination with another medication. Most studies in this regard are retrospective in nature, with only a handful of prospective studies. To date, no randomized controlled trials have been performed to address anesthetic regimens to perform DISE in children. One randomized controlled trial in adults compared Propofol and Dexmedetomidine as anesthetic regimens for DISE and concluded that Dexmedetomidine could satisfy the DISE requirement and had no significant side effects on cardiovascular changes and less interference of breathing. Given the difference between children and adults in pathophysiology, risk factors for the diseases and tolerance of medication, the findings cannot be claimed to be similar in children unless proven. The aim is to perform a head-to-head study comparing the 2 commonly used regimens Propofol and Dexmedetomidine in children with SDB. This helps us identify a safer and more efficacious regimen that can be a standardized DISE protocol in the pediatric population in the future.
- Being tested
- Propofol, Dexmedetomidine
- Keywords
- Drug induced sleep endoscopy, sleep disordered breathing, DISE directed surgery, children
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan, Fresenius Propoven, Propofol-Lipuro, Propofol-II [DSC]
Propofol will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Arm 1: Propofol
1. PO Versed (Benzodiazepine) preoperatively
2. Obtain baseline bispectral index (BIS) monitor
3. Mask induction with Sevoflurane
4. Intravenous access
5. Propofol bolus 0.5-2 mg/kg to start followed by infusion 200-350 mcg/kg/min
6. Wait around 2 minutes
7. BIS monitor with Propofol on board Receives: Drug: Propofol |
| Dexmedetomidine | Active comparator | Arm 2: Dexmedetomidine
1. PO Versed (Benzodiazepine) preoperatively
2. Obtain baseline BIS monitor
3. Mask induction with Sevoflurane
4. Intravenous access
5. Dexmedetomidine bolus 0.5-3 mcg/kg to start followed by infusion 0.5-2mcg/kg/hr
6. Wait around 10 mins
7. BIS monitor with Dexmedetomidine on board Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Dexmedetomidine and Propofol for successful DISE (Drug Induced Sleep Endoscopy) procedure in-terms regarding which drug works better without causing side effects
Measured: 5-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jun 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: PI moved to another institution
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 Sleep Disordered BreathingStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will randomize n=120 study participants undergoing DISE to one of two anesthetic agents, Propofol or Dexmedetomidine. With equal allocation to each arm (n=60 per group).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sohit Kanotra, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756971
- Sponsor's protocol ID
- 202011387
- Status last verified
- Jan 2025
- First submitted
- 21 May 2022
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman NR, Parikh SR, Ishman SL, Ruiz AG, El-Hakim H, Ulualp SO, Wootten CT, Koltai PJ, Chan DK. The current state of pediatric drug-induced sleep endoscopy. Laryngoscope. 2017 Jan;127(1):266-272. doi: 10.1002/lary.26091. Epub 2016 Jun 16.
PubMed 27311407Liu KA, Liu CC, Alex G, Szmuk P, Mitchell RB. Anesthetic management of children undergoing drug-induced sleep endoscopy: A retrospective review. Int J Pediatr Otorhinolaryngol. 2020 Dec;139:110440. doi: 10.1016/j.ijporl.2020.110440. Epub 2020 Oct 14.
PubMed 33080472Zhao 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 30515416Kandil A, Subramanyam R, Hossain MM, Ishman S, Shott S, Tewari A, Mahmoud M. Comparison of the combination of dexmedetomidine and ketamine to propofol or propofol/sevoflurane for drug-induced sleep endoscopy in children. Paediatr Anaesth. 2016 Jul;26(7):742-51. doi: 10.1111/pan.12931. Epub 2016 May 23.
PubMed 27212000Gazzaz MJ, Isaac A, Anderson S, Alsufyani N, Alrajhi Y, El-Hakim H. Does drug-induced sleep endoscopy change the surgical decision in surgically naive non-syndromic children with snoring/sleep disordered breathing from the standard adenotonsillectomy? A retrospective cohort study. J Otolaryngol Head Neck Surg. 2017 Feb 13;46(1):12. doi: 10.1186/s40463-017-0190-6.
PubMed 28193298Baldassari CM, Lam DJ, Ishman SL, Chernobilsky B, Friedman NR, Giordano T, Lawlor C, Mitchell RB, Nardone H, Ruda J, Zalzal H, Deneal A, Dhepyasuwan N, Rosenfeld RM. Expert Consensus Statement: Pediatric Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2021 Oct;165(4):578-591. doi: 10.1177/0194599820985000. Epub 2021 Jan 5.
PubMed 33400611
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol and Dexmedetomidine as Anesthetic Protocols for Drug Induced Sleep Endoscopy (DISE) in Pediatric Patients With Sleep Disordered Breathing: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06756971
- Acronym / sponsor ID
- 202011387
- Keywords
- Drug induced sleep endoscopy, sleep disordered breathing, DISE directed surgery, children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 3 Jan 2025 (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.
Adenotonsillar hypertrophy is the most common reason for children to have sleep disordered breathing (SDB). Even though adenotonsillectomy improves sleep apnea in children, 20-40% of children will still have persistent SDB. Drug Induced Sleep Endoscopy (DISE) is a tool that dynamically evaluates the upper airway during simulated sleep. It identifies sites of upper airway obstruction and/or collapse. It is used to predict which children will get better if their tonsils and adenoids are removed, and which children have other reasons for SDB. DISE is done during a state of simulated sleep. Different anesthetic medications are currently being used. However, there is no identified ideal anesthetic medication to simulate natural sleep. Propofol and Dexmedetomidine are the most frequently used, either alone or in combination with other medications. The aim is to perform a head-to-head study comparing those 2 commonly used regimens. The investigator would like to learn how the anesthetic medication affects performing the procedure and how well our patients tolerate it. This helps us identify an ideal regimen that can be a standardized DISE protocol in the pediatric population in the future. Our objective is to determine which anesthetic regimen, Dexmedetomidine or Propofol, is safer and more efficacious. This will be a randomized controlled trial at the University of Iowa Stead Family Children's Hospital. Children with sleep disordered breathing will undergo DISE and subsequent surgical procedure based on the level of obstruction found during DISE. Via randomization the child will be preselected to have a specific anesthetic for the procedure, either Dexmedetomidine or Propofol. The investigator will record information related to the medications used, the vital signs, the ability to perform DISE fully, the findings seen on DISE and the surgery performed. Consent will be obtained from the legal guardian or parent with legal authority to consent.
Detailed description
Drug-induced sleep endoscopy (DISE) in children has gained popularity in the past 10 years. Its most valuable use is in patients with sleep disordered breathing (SDB). DISE is capable of identifying dynamic sites of upper airway obstruction and or collapse during sleep, beyond the tonsils and adenoids. It is also capable of identifying the degree of dynamic obstruction caused by different anatomical structures. Currently, pediatric patients with SDB diagnosed either clinically with the help of a validated sleep questionnaire or on the basis of sleep study and undergo surgery depending on the level of the obstruction. The surgery most commonly performed is adenotonsillectomy. In order to diagnose the level of obstruction DISE is performed. Currently, there is a lack in consensus regarding the ideal anesthetic regimen to simulate natural sleep and poor agreement regarding DISE anesthetic protocols among experts. An ideal agent would provide sufficient analgesia under near-physiologic settings and prevent substantial airway collapse, respiratory depression, and cardiovascular effects. It should have a predictable period of action and a smooth emergence. Multiple anesthetic regimens have been used for DISE. This includes inhalation anesthesia such as Sevoflurane, total intravenous anesthesia (TIVA) such as Propofol alone or with Remifentanil, and Dexmedetomidine alone or with Ketamine. Propofol and Dexmedetomidine are the most frequently used regimens, either alone or in combination with another medication. Most studies in this regard are retrospective in nature, with only a handful of prospective studies. To date, no randomized controlled trials have been performed to address anesthetic regimens to perform DISE in children. One randomized controlled trial in adults compared Propofol and Dexmedetomidine as anesthetic regimens for DISE and concluded that Dexmedetomidine could satisfy the DISE requirement and had no significant side effects on cardiovascular changes and less interference of breathing. Given the difference between children and adults in pathophysiology, risk factors for the diseases and tolerance of medication, the findings cannot be claimed to be similar in children unless proven. The aim is to perform a head-to-head study comparing the 2 commonly used regimens Propofol and Dexmedetomidine in children with SDB. This helps us identify a safer and more efficacious regimen that can be a standardized DISE protocol in the pediatric population in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will randomize n=120 study participants undergoing DISE to one of two anesthetic agents, Propofol or Dexmedetomidine. With equal allocation to each arm (n=60 per group).
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolArm 1: Propofol 1. PO Versed (Benzodiazepine) preoperatively 2. Obtain baseline bispectral index (BIS) monitor 3. Mask induction with Sevoflurane 4. Intravenous access 5. Propofol bolus 0.5-2 mg/kg to start followed by infusion 200-350 mcg/kg/min 6. Wait around 2 minutes 7. BIS monitor with Propofol on board |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineArm 2: Dexmedetomidine 1. PO Versed (Benzodiazepine) preoperatively 2. Obtain baseline BIS monitor 3. Mask induction with Sevoflurane 4. Intravenous access 5. Dexmedetomidine bolus 0.5-3 mcg/kg to start followed by infusion 0.5-2mcg/kg/hr 6. Wait around 10 mins 7. BIS monitor with Dexmedetomidine on board |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children 1 month-18 years of age
- Clinical diagnosis of sleep disordered breathing (SDB) either based on a Pediatric sleep questionnaire (>33% on modified Pediatric Sleep Questionnaire (PSQ)) or Sleep study
- Subject is deemed a surgical candidate for undergoing DISE, adenotonsillectomy or DISE directed surgery
Key exclusion criteria (5 listed)
- Adult patients
- Hypersensitivity to propofol or dexmedetomidine or any of their components,
- Allergies to eggs, egg products, soybeans, or soy products,
- Congenital cardiac disease, cardiac conduction system pathology, and increased pulmonary artery pressure or decreased cardiac output (e.g., right-sided heart failure, septic shock).
- Children who are receiving medicines with rate-slowing action on the atrioventricular node (eg, digoxin, nifedipine)
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 |
|---|---|---|
| PropofolAlso: Diprivan, Fresenius Propoven, Propofol-Lipuro, Propofol-II [DSC]Propofol will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation | Drug | Propofol |
| DexmedetomidineAlso: PrecedexDexmedetomidine will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation | Drug | Dexmedetomidine |
Primary outcome
Comparing Dexmedetomidine and Propofol for successful DISE (Drug Induced Sleep Endoscopy) procedure in-terms regarding which drug works better without causing side effects
Time frame: 5-20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 27311407Friedman NR, Parikh SR, Ishman SL, Ruiz AG, El-Hakim H, Ulualp SO, Wootten CT, Koltai PJ, Chan DK. The current state of pediatric drug-induced sleep endoscopy. Laryngoscope. 2017 Jan;127(1):266-272. doi: 10.1002/lary.26091. Epub 2016 Jun 16.
- Background: PubMed 33080472Liu KA, Liu CC, Alex G, Szmuk P, Mitchell RB. Anesthetic management of children undergoing drug-induced sleep endoscopy: A retrospective review. Int J Pediatr Otorhinolaryngol. 2020 Dec;139:110440. doi: 10.1016/j.ijporl.2020.110440. Epub 2020 Oct 14.
- 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 27212000Kandil A, Subramanyam R, Hossain MM, Ishman S, Shott S, Tewari A, Mahmoud M. Comparison of the combination of dexmedetomidine and ketamine to propofol or propofol/sevoflurane for drug-induced sleep endoscopy in children. Paediatr Anaesth. 2016 Jul;26(7):742-51. doi: 10.1111/pan.12931. Epub 2016 May 23.
- Background: PubMed 28193298Gazzaz MJ, Isaac A, Anderson S, Alsufyani N, Alrajhi Y, El-Hakim H. Does drug-induced sleep endoscopy change the surgical decision in surgically naive non-syndromic children with snoring/sleep disordered breathing from the standard adenotonsillectomy? A retrospective cohort study. J Otolaryngol Head Neck Surg. 2017 Feb 13;46(1):12. doi: 10.1186/s40463-017-0190-6.
- Background: PubMed 33400611Baldassari CM, Lam DJ, Ishman SL, Chernobilsky B, Friedman NR, Giordano T, Lawlor C, Mitchell RB, Nardone H, Ruda J, Zalzal H, Deneal A, Dhepyasuwan N, Rosenfeld RM. Expert Consensus Statement: Pediatric Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2021 Oct;165(4):578-591. doi: 10.1177/0194599820985000. Epub 2021 Jan 5.
- 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.
Sohit Kanotra, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propofol and Dexmedetomidine in people with Sleep Disordered Breathing and Drug Induced Sleep Disorder, run by University of Iowa.
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 3 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: withdrawn, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparing Dexmedetomidine and Propofol for successful DISE (Drug Induced Sleep Endoscopy) procedure in-terms regarding which drug works better without causing side effects (time frame: 5-20 minutes). 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 NCT06756971, 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 3 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.