Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Christopher M Cielo, DO
cieloc@chop.edu
2674265748
Backup
Ignacio E Tapia, MD
itapia@miami.edu
305-243-9885
Time Frame
Start Date: 2023-03-29
Estimated Completion Date: 2027-07
Participants
Target number of participants: 317
Treatments
Experimental: HSAT first
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Active_comparator: PSG first
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: University of Miami, National Heart, Lung, and Blood Institute (NHLBI)