Sleep Apnea, ObstructiveHOM-KidsNCT05516524
HSAT for OSA Management in Children
A study testing Home sleep apnea test and PSG in people with Sleep Apnea, Obstructive and Sleep Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes
- What is being tested?
- Home sleep apnea test and PSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 17 Sep 2025
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children age 5-12 years old inclusive
- History of adenotonsillectomy for OSA
Who cannot join
- Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
- Children with a tracheostomy or tracheocutaneous fistula
- Children who live in a facility without their parent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
Read the detailed description
Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.
- Being tested
- Home sleep apnea test, PSG
- Keywords
- obstructive sleep apnea, home sleep apnea testing
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders, Sleep Apnea Syndromes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home sleep apnea testDiagnostic test
Also called Nox A1, HSAT
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
PSGDiagnostic test
Also called In-Lab Polysomnography
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
| Study group | Role | What they receive |
|---|---|---|
| HSAT prior to clinical sleep study | Experimental | Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography Receives: Diagnostic Test: Home sleep apnea test |
| PSG first Participants will be random | Active comparator | Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. Receives: Diagnostic Test: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests
Measured: up to one month
Secondary outcomes (4)
Correlation between OAHI from HSAT and score from OSA questionnaires
Correlation between OAHI from HSAT will be measured by completion of the Pediatric Sleep Questionnaire-Sleep Related Breathing Disorders scale (PSQ-SRBD) and OSA-18 Questionnaire. . The PSQ-SRBD is a 22-item questionnaire where a score of >0.33 is consistent with a diagnosis of OSA. The OSA-18 consists of 18 questions for which the overall total scores will assess for OSA risk. Total scores range from 18 to 126, with 18 indicating low risk of OSA and 126 indicating high risk of OSA.
Measured: up to one month
Parent-reported preference between HSAT and PSG
Parent-reported preference between HSAT and PSG will be measured by the parents' completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT.
Measured: up to one month
Child-reported preference between HSAT and PSG
Child-reported preference between HSAT and PSG will be measured by the child's completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT.
Measured: up to one month
Parent-reported acceptability of HSAT
Parent-reported acceptability of HSAT will be measures by the parents' completion of the acceptability questionnaire after completion of both studies. The questionnaire contains 4 questions for which the overall score will assess for preference. Total scores range from 4 to 20, with 4 indicating a strong preference for HSAT and 20 indicating a low preference for HSAT.
Measured: up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Dec 2022
- Primary completion10 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Christopher M Cielo, DO, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516524
- Sponsor's protocol ID
- 22-020232
- Acronym
- HOM-Kids
- Status last verified
- Oct 2025
- First submitted
- 23 Aug 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bixler EO, Vgontzas AN, Lin HM, Liao D, Calhoun S, Vela-Bueno A, Fedok F, Vlasic V, Graff G. Sleep disordered breathing in children in a general population sample: prevalence and risk factors. Sleep. 2009 Jun;32(6):731-6. doi: 10.1093/sleep/32.6.731.
PubMed 19544748Li AM, So HK, Au CT, Ho C, Lau J, Ng SK, Abdullah VJ, Fok TF, Wing YK. Epidemiology of obstructive sleep apnoea syndrome in Chinese children: a two-phase community study. Thorax. 2010 Nov;65(11):991-7. doi: 10.1136/thx.2010.134858.
PubMed 20965935Horne RS, Yang JS, Walter LM, Richardson HL, O'Driscoll DM, Foster AM, Wong S, Ng ML, Bashir F, Patterson R, Nixon GM, Jolley D, Walker AM, Anderson V, Trinder J, Davey MJ. Elevated blood pressure during sleep and wake in children with sleep-disordered breathing. Pediatrics. 2011 Jul;128(1):e85-92. doi: 10.1542/peds.2010-3431. Epub 2011 Jun 27.
PubMed 21708802Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.
PubMed 23692173Gozal D, Crabtree VM, Sans Capdevila O, Witcher LA, Kheirandish-Gozal L. C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children. Am J Respir Crit Care Med. 2007 Jul 15;176(2):188-93. doi: 10.1164/rccm.200610-1519OC. Epub 2007 Mar 30.
PubMed 17400731Schwab RJ, Kim C, Bagchi S, Keenan BT, Comyn FL, Wang S, Tapia IE, Huang S, Traylor J, Torigian DA, Bradford RM, Marcus CL. Understanding the anatomic basis for obstructive sleep apnea syndrome in adolescents. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1295-309. doi: 10.1164/rccm.201501-0169OC.
PubMed 25835282Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
PubMed 28256998Bhattacharjee R, Kheirandish-Gozal L, Spruyt K, Mitchell RB, Promchiarak J, Simakajornboon N, Kaditis AG, Splaingard D, Splaingard M, Brooks LJ, Marcus CL, Sin S, Arens R, Verhulst SL, Gozal D. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2010 Sep 1;182(5):676-83. doi: 10.1164/rccm.200912-1930OC. Epub 2010 May 6.
PubMed 20448096Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2009 Jun;140(6):800-8. doi: 10.1016/j.otohns.2009.01.043.
PubMed 19467393Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
PubMed 22926173Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
PubMed 26541535Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
PubMed 22926176Rosen IM, Kirsch DB, Chervin RD, Carden KA, Ramar K, Aurora RN, Kristo DA, Malhotra RK, Martin JL, Olson EJ, Rosen CL, Rowley JA; American Academy of Sleep Medicine Board of Directors. Clinical Use of a Home Sleep Apnea Test: An American Academy of Sleep Medicine Position Statement. J Clin Sleep Med. 2017 Oct 15;13(10):1205-1207. doi: 10.5664/jcsm.6774.
PubMed 28942762Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
PubMed 28162150Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. Am J Respir Crit Care Med. 2011 May 1;183(9):1238-44. doi: 10.1164/rccm.201011-1770OC. Epub 2011 Jan 21.
PubMed 21471093
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT05516524
- Acronym / sponsor ID
- HOM-Kids / 22-020232
- Keywords
- obstructive sleep apnea, home sleep apnea testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 25 Aug 2022 (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.
This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
Detailed description
Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
| Arm | Type | Receives |
|---|---|---|
| HSAT prior to clinical sleep study | Experimental | Diagnostic Test: Home sleep apnea testParticipants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography |
| PSG first Participants will be random | Active comparator | Diagnostic Test: PSGParticipants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female children age 5-12 years old inclusive
- History of adenotonsillectomy for OSA
Key exclusion criteria (3 listed)
- Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
- Children with a tracheostomy or tracheocutaneous fistula
- Children who live in a facility without their parent
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 |
|---|---|---|
| Home sleep apnea testAlso: Nox A1, HSATLevel II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision. | Diagnostic test | HSAT prior to clinical sleep study |
| PSGAlso: In-Lab PolysomnographyOvernight sleep study in the sleep laboratory with continuous monitoring by clinical staff. | Diagnostic test | PSG first Participants will be random |
Primary outcome
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
Time frame: up to one month
Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests
4 secondary outcomes
Correlation between OAHI from HSAT and score from OSA questionnaires
Time frame: up to one month
Parent-reported preference between HSAT and PSG
Time frame: up to one month
Child-reported preference between HSAT and PSG
Time frame: up to one month
Parent-reported acceptability of HSAT
Time frame: up to one month.
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 14 Oct 2025.
- Background: PubMed 19544748Bixler EO, Vgontzas AN, Lin HM, Liao D, Calhoun S, Vela-Bueno A, Fedok F, Vlasic V, Graff G. Sleep disordered breathing in children in a general population sample: prevalence and risk factors. Sleep. 2009 Jun;32(6):731-6. doi: 10.1093/sleep/32.6.731.
- Background: PubMed 20965935Li AM, So HK, Au CT, Ho C, Lau J, Ng SK, Abdullah VJ, Fok TF, Wing YK. Epidemiology of obstructive sleep apnoea syndrome in Chinese children: a two-phase community study. Thorax. 2010 Nov;65(11):991-7. doi: 10.1136/thx.2010.134858.
- Background: PubMed 21708802Horne RS, Yang JS, Walter LM, Richardson HL, O'Driscoll DM, Foster AM, Wong S, Ng ML, Bashir F, Patterson R, Nixon GM, Jolley D, Walker AM, Anderson V, Trinder J, Davey MJ. Elevated blood pressure during sleep and wake in children with sleep-disordered breathing. Pediatrics. 2011 Jul;128(1):e85-92. doi: 10.1542/peds.2010-3431. Epub 2011 Jun 27.
- Background: PubMed 23692173Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.
- Background: PubMed 17400731Gozal D, Crabtree VM, Sans Capdevila O, Witcher LA, Kheirandish-Gozal L. C-reactive protein, obstructive sleep apnea, and cognitive dysfunction in school-aged children. Am J Respir Crit Care Med. 2007 Jul 15;176(2):188-93. doi: 10.1164/rccm.200610-1519OC. Epub 2007 Mar 30.
- Background: PubMed 25835282Schwab RJ, Kim C, Bagchi S, Keenan BT, Comyn FL, Wang S, Tapia IE, Huang S, Traylor J, Torigian DA, Bradford RM, Marcus CL. Understanding the anatomic basis for obstructive sleep apnea syndrome in adolescents. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1295-309. doi: 10.1164/rccm.201501-0169OC.
- Background: PubMed 28256998Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
- Background: PubMed 20448096Bhattacharjee R, Kheirandish-Gozal L, Spruyt K, Mitchell RB, Promchiarak J, Simakajornboon N, Kaditis AG, Splaingard D, Splaingard M, Brooks LJ, Marcus CL, Sin S, Arens R, Verhulst SL, Gozal D. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2010 Sep 1;182(5):676-83. doi: 10.1164/rccm.200912-1930OC. Epub 2010 May 6.
- Background: PubMed 19467393Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2009 Jun;140(6):800-8. doi: 10.1016/j.otohns.2009.01.043.
- Background: PubMed 22926173Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
- Background: PubMed 26541535Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
- Background: PubMed 22926176Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
- 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.
Christopher M Cielo, DO principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home sleep apnea test and PSG in people with Sleep Apnea, Obstructive and Sleep Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
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 2 inclusion and 3 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 14 Oct 2025. 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 States. 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?
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG (time frame: up to one month). 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 NCT05516524, which also lists 33 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 14 Oct 2025.