Sleep Apnea, ObstructiveHATCHNCT05382754
Home Apnea Testing in CHildren Trial
A study testing Home sleep apnea test and In-lab polysomnography 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 home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea. 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 In-lab polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 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
- Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Children without Down syndrome who have had a PSG within 3 years of enrollment
- Children with Down syndrome who have had a PSG within 1 year of enrollment.
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Yaelis Roman-Rosado, 215-590-9184, romanyd@chop.edu
Christopher M Cielo, DO
About this study
Official title: Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.
Read the detailed description
In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test.
Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.
- Being tested
- Home sleep apnea test, In-lab polysomnography
- 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.
In-lab polysomnographyDiagnostic test
Also called PSG
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
| Study group | Role | What they receive |
|---|---|---|
| HSAT first | Experimental | Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography Receives: Diagnostic Test: Home sleep apnea test |
| PSG first | Active comparator | Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. Receives: Diagnostic Test: In-lab polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with diagnosis of OSA on both HSAT and PSG
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).
Measured: 2 weeks
Secondary outcomes (3)
Association between therapeutic decision from HSAT compared to PSG
Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test.
Measured: 2 weeks
Proportion of participants who prefer HSAT to PSG
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Measured: 2 weeks
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start29 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)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 one week.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Miami
- Responsible party
- Sponsor
- Investigators
- Christopher M Cielo, DO, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382754
- Sponsor's protocol ID
- 21-019533
- Other IDs
- 1R61HL162839-01
- Acronym
- HATCH
- Status last verified
- Apr 2026
- First submitted
- 16 May 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionaries) will be made available upon reasonable request after completion of the trial and publication of the primary results. Access will be provided following review and approval of a research proposal, with a signed data use agreement and any necessary ethical approvals.
Publications
Marcus CL, Traylor J, Biggs SN, Roberts RS, Nixon GM, Narang I, Bhattacharjee R, Davey MJ, Horne RS, Cheshire M, Gibbons KJ, Dix J, Asztalos E, Doyle LW, Opie GF, D'ilario J, Costantini L, Bradford R, Schmidt B. Feasibility of comprehensive, unattended ambulatory polysomnography in school-aged children. J Clin Sleep Med. 2014 Aug 15;10(8):913-8. doi: 10.5664/jcsm.3970.
PubMed 25126039Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. doi: 10.1093/sleep/24.8.937.
PubMed 11766164Guilleminault C, Lee JH, Chan A. Pediatric obstructive sleep apnea syndrome. Arch Pediatr Adolesc Med. 2005 Aug;159(8):775-85. doi: 10.1001/archpedi.159.8.775.
PubMed 16061787Bixler 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 17400731Marcus 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 22926173Das S, Mindell J, Millet GC, Ofer D, Beck SE, Mason TB, Brooks LJ, Traylor J, Marcus CL. Pediatric polysomnography: the patient and family perspective. J Clin Sleep Med. 2011 Feb 15;7(1):81-7.
PubMed 21344042Rosen 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 21471093Berry RB, Hill G, Thompson L, McLaurin V. Portable monitoring and autotitration versus polysomnography for the diagnosis and treatment of sleep apnea. Sleep. 2008 Oct;31(10):1423-31.
PubMed 18853940Skomro RP, Gjevre J, Reid J, McNab B, Ghosh S, Stiles M, Jokic R, Ward H, Cotton D. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest. 2010 Aug;138(2):257-63. doi: 10.1378/chest.09-0577. Epub 2010 Feb 19.
PubMed 20173052
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
- ClinicalTrials.gov ID
- NCT05382754
- Acronym / sponsor ID
- HATCH / 21-019533
- Keywords
- obstructive sleep apnea, home sleep apnea testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Miami
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 May 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 home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.
Detailed description
In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test.
Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- 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 one week.
| Arm | Type | Receives |
|---|---|---|
| HSAT first | Experimental | Diagnostic Test: Home sleep apnea testParticipants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography |
| PSG first | Active comparator | Diagnostic Test: In-lab polysomnographyParticipants 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 (3 listed)
- Male and female children age 5-12 years old inclusive
- Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Key exclusion criteria (5 listed)
- Children without Down syndrome who have had a PSG within 3 years of enrollment
- Children with Down syndrome who have had a PSG within 1 year of enrollment.
- 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 first |
| In-lab polysomnographyAlso: PSGOvernight sleep study in the sleep laboratory with continuous monitoring by clinical staff. | Diagnostic test | PSG first |
Primary outcome
Proportion of participants with diagnosis of OSA on both HSAT and PSG
Time frame: 2 weeks
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).
3 secondary outcomes
Association between therapeutic decision from HSAT compared to PSG
Time frame: 2 weeks
Proportion of participants who prefer HSAT to PSG
Time frame: 2 weeks
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 25126039Marcus CL, Traylor J, Biggs SN, Roberts RS, Nixon GM, Narang I, Bhattacharjee R, Davey MJ, Horne RS, Cheshire M, Gibbons KJ, Dix J, Asztalos E, Doyle LW, Opie GF, D'ilario J, Costantini L, Bradford R, Schmidt B. Feasibility of comprehensive, unattended ambulatory polysomnography in school-aged children. J Clin Sleep Med. 2014 Aug 15;10(8):913-8. doi: 10.5664/jcsm.3970.
- Background: PubMed 11766164Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. doi: 10.1093/sleep/24.8.937.
- Background: PubMed 16061787Guilleminault C, Lee JH, Chan A. Pediatric obstructive sleep apnea syndrome. Arch Pediatr Adolesc Med. 2005 Aug;159(8):775-85. doi: 10.1001/archpedi.159.8.775.
- 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 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 21344042Das S, Mindell J, Millet GC, Ofer D, Beck SE, Mason TB, Brooks LJ, Traylor J, Marcus CL. Pediatric polysomnography: the patient and family perspective. J Clin Sleep Med. 2011 Feb 15;7(1):81-7.
- Background: PubMed 28942762Rosen 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.
- Background: PubMed 28162150Kapur 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionaries) will be made available upon reasonable request after completion of the trial and publication of the primary results. Access will be provided following review and approval of a research proposal, with a signed data use agreement and any necessary ethical approvals.
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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.
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 In-lab polysomnography 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 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher M Cielo, DO (2674265748, cieloc@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with diagnosis of OSA on both HSAT and PSG (time frame: 2 weeks). 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 NCT05382754, which also lists 23 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 21 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.