Home Apnea Testing in CHildren Trial

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Sleep Disorders

Treatment

Home sleep apnea test

In-lab polysomnography

Clinical Study ID

NCT05382754

21-019533

1R61HL162839-01

Ages 5-12
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Male and female children age 5-12 years old inclusive
Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) SleepLaboratory for evaluation of OSA as part of clinical care
Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion

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 supplementaloxygen or positive airway pressure during sleep
Children with a tracheostomy or tracheocutaneous fistula
Children who live in a facility without their parent

Study Design

Home sleep apnea test

March 29, 2023

July 31, 2027

Study 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.

Connect with a study center

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Active - Recruiting

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