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Recruiting Not applicable NCT05382754

Home Apnea Testing in CHildren Trial

No applicable phase (e.g. observational)
Conditions: Sleep Apnea, Obstructive Sleep Disorder Sleep Apnea Syndromes Sleep Disturbance

Sponsor: Children's Hospital of Philadelphia

trial.available_in: БГ
Overview
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.
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 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.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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
Interventions
Home sleep apnea test
DIAGNOSTIC_TEST
In-lab polysomnography
DIAGNOSTIC_TEST
Locations 1
United States (1)
The Children's Hospital of Philadelphia
Philadelphia , Pennsylvania
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
5 Years
Maximum age
12 Years
Healthy volunteers
No
Start date
29.03.2023
Completion date
01.07.2027
Registry ID
NCT05382754
Source
clinicaltrials.gov
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