Clinical trial NCT05382754: Home Apnea Testing in CHildren Trial
Official title: Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Disorder
Sleep Apnea Syndromes
Sleep Disturbance
Keywords: obstructive sleep apnea
home sleep apnea testing
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Miami
First posted: 2022-05-19
Enrollment: 317
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within one week.
Primary purpose: DIAGNOSTIC

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 children referred for evaluation of obstructive sleep apnea.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with diagnosis of OSA on both HSAT and PSG
timeFrame: 2 weeks
Secondary outcomes:
measure: Association between therapeutic decision from HSAT compared to PSG
timeFrame: 2 weeks
measure: Proportion of participants who prefer HSAT to PSG
timeFrame: 2 weeks
measure: Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christopher M Cielo, DO
role: PRINCIPAL_INVESTIGATOR
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