RecruitingNot ApplicableNCT05382754

Home Apnea Testing in CHildren Trial

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


Sponsor

Children's Hospital of Philadelphia

Enrollment

317 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 12 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTHome sleep apnea test

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

DIAGNOSTIC_TESTIn-lab polysomnography

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


Locations(1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT05382754


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