HATCH: Home Apnea Testing in CHildren Trial

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05382754

Collaborator

National Institutes of Health (NIH) (NIH)

317

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Sleep Disorder Sleep Apnea Syndromes Sleep Disturbance	Diagnostic Test: Home sleep apnea test Diagnostic Test: In-lab polysomnography	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

317 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within one week.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The investigators will be masked as to the order of the two sleep tests

Primary Purpose:

Diagnostic

Official Title:

Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HSAT first Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography	Diagnostic Test: Home sleep apnea test Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision. Other Names: NOX A1 HSAT
Active Comparator: PSG first Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.	Diagnostic Test: In-lab polysomnography Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff. Other Names: PSG

Arm

Intervention/Treatment

Experimental: HSAT first

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

Diagnostic Test: Home sleep apnea test

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

Other Names:

NOX A1

HSAT

Active Comparator: PSG first

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

Diagnostic Test: In-lab polysomnography

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

Other Names:

PSG

Outcome Measures

Primary Outcome Measures

Proportion of participants with diagnosis of OSA on both HSAT and PSG [2 weeks]
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).

Secondary Outcome Measures

Association between therapeutic decision from HSAT compared to PSG [2 weeks]
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.
Proportion of participants who prefer HSAT to PSG [2 weeks]
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG [2 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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 who have had a PSG within 3 years 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