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Home Apnea Testing in CHildren Trial

ConditionsSleep Apnea, ObstructiveSleep DisorderSleep Apnea SyndromesSleep Disturbance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorChildren's Hospital of Philadelphia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Home sleep apnea test

    Diagnostic test

    Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.

  • In-lab polysomnography

    Diagnostic test

    Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Treatment groups

317 Participants
are divided into 2 treatment groups
Group A: HSAT firstExperimental treatment 1 intervention
Group B: PSG firstActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with diagnosis of OSA on both HSAT and PSG

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

Secondary outcomes

1

Association between therapeutic decision from HSAT compared to PSG

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
2

Proportion of participants who prefer HSAT to PSG

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
3

Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG

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).

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Miami

Collaborator

Source ClinicalTrials.gov
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