Status:
RECRUITING
Home Apnea Testing in CHildren Trial
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Miami
Conditions:
Sleep Apnea, Obstructive
Sleep Disorder
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief 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 ch...
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 und...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT05382754
Start Date
March 29 2023
End Date
July 1 2027
Last Update
April 13 2025
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104