Home Apnea Testing in CHildren Trial (HATCH)

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep Apnea, Obstructive; Sleep Disturbance

Treatments: Diagnostic Test: In-lab polysomnography; Diagnostic Test: Home sleep apnea test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05382754

21-019533

1R61HL162839-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 317 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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317 participants in 2 patient groups

HSAT first

Experimental group

Description:

Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography

Treatment:

Diagnostic Test: Home sleep apnea test

PSG first

Active Comparator group

Description:

Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.

Treatment:

Diagnostic Test: In-lab polysomnography