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Home Apnea Testing in CHildren Trial

NCT05382754 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Disorder
  • Sleep Apnea Syndromes
  • Sleep Disturbance

Interventions

DIAGNOSTIC_TEST

Home sleep apnea test

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

DIAGNOSTIC_TEST

In-lab polysomnography

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

Sponsors & Collaborators

Principal Investigators

  • Christopher M Cielo, DO · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382754 on ClinicalTrials.gov