Home Apnea Testing in CHildren Trial (HATCH)

April 16, 2026 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christopher M Cielo, DO
  • Phone Number: 2674265748
  • Email: cieloc@chop.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Principal Investigator:
          • Christopher M Cielo, DO
        • Sub-Investigator:
          • Ignacio E Tapia, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HSAT first
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Diagnostic test: Home sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
Other Names:
  • HSAT
  • NOX A1
Active Comparator: PSG first
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
Diagnostic test: In-lab polysomnography
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Other Names:
  • PSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between therapeutic decision from HSAT compared to PSG
Time Frame: 2 weeks
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.
2 weeks
Proportion of participants who prefer HSAT to PSG
Time Frame: 2 weeks
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
2 weeks
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Time Frame: 2 weeks
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).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
University of Miami

Investigators

  • Principal Investigator: Christopher M Cielo, DO, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-019533
  • 1R61HL162839-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

It is anticipated that the data from this study will be used to guide future evidence-based guidelines regarding the evaluation of OSA in children. We will submit to the National Library of Medicine's PubMed Central an electronic version of the final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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