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HSAT for OSA Management in Children

NCT05516524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-10-14

No results posted yet for this study

Summary

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

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

PSG

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
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-09-10
Completion
2025-09-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05516524 on ClinicalTrials.gov