The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Christopher M Cielo, DO
PRINCIPAL_INVESTIGATOR
Ignacio E Tapia, MD
SUB_INVESTIGATOR
Yaelis Roman-Rosado
CONTACT
NCT Number: NCT05382754
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.
Interested in participating?
Request Info5 year–12 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Christopher M Cielo, DO
PRINCIPAL_INVESTIGATOR
Ignacio E Tapia, MD
SUB_INVESTIGATOR
Yaelis Roman-Rosado
CONTACT
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 undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test.
Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
Other names: NOX A1, HSAT
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Other names: PSG
Time frame: 2 weeks
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).
Time frame: 2 weeks
Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test.
Time frame: 2 weeks
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Time frame: 2 weeks
Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT).
Contact information is provided by the study sponsor or research team.
Christopher M Cielo, DO
CONTACT
Ignacio E Tapia, MD
CONTACT
Children's Hospital of Philadelphia
Other
Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Acronym: HATCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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