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NCT Number: NCT05382754

Home Apnea Testing in CHildren Trial

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Christopher M Cielo, DO

PRINCIPAL_INVESTIGATOR

Ignacio E Tapia, MD

SUB_INVESTIGATOR

Yaelis Roman-Rosado

CONTACT

[email protected]

215-590-9184

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home sleep apnea test

Diagnostic Test

Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.

Other names: NOX A1, HSAT

In-lab polysomnography

Diagnostic Test

Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Other names: PSG

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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. 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

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher M Cielo, DO

CONTACT

[email protected]

2674265748

Ignacio E Tapia, MD

CONTACT

[email protected]

305-243-9885

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

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

Registry information

Official study title

Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children

Acronym: HATCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 19, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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