Home Apnea Testing in CHildren Trial

NCT05382754 | Recruiting DMC FDA Device

• 2 other identifiers: 21-0195331R61HL162839-01
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

obstructive sleep apnea; home sleep apnea testing

Outcome Measures

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).

  2 weeks

Secondary Outcomes (3)

• Association between therapeutic decision from HSAT compared to PSG

  2 weeks

• Proportion of participants who prefer HSAT to PSG

  2 weeks

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

  2 weeks

Study Arms (2)

HSAT first

EXPERIMENTAL

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

Diagnostic Test: Home sleep apnea test

PSG first

ACTIVE COMPARATOR

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

Diagnostic Test: In-lab polysomnography

Interventions

Home sleep apnea test DIAGNOSTIC_TEST

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

Also known as: NOX A1, HSAT

HSAT first

In-lab polysomnography DIAGNOSTIC_TEST

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

Also known as: PSG

PSG first

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Miami: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (23)

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  BACKGROUND

• Roman Rosado YD, Somayaji M, Stefanovski D, Uwah EA, Ward M, Tapia IE, Galion A, DelRosso LM, Davidson Ward SL, Cielo CM. Randomised trial of home sleep apnoea testing compared to in-lab polysomnography for the evaluation of obstructive sleep apnoea in children: rationale and study protocol. BMJ Open. 2025 Jun 24;15(6):e103315. doi: 10.1136/bmjopen-2025-103315.

  PMID: 40555446 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Sleep Apnea Syndromes; Parasomnias

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Christopher M Cielo, DO

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher M Cielo, DO

CONTACT

2674265748; cieloc@chop.edu

Ignacio E Tapia, MD

CONTACT

305-243-9885; itapia@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators will be masked as to the order of the two sleep tests
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: March 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It is anticipated that the data from this study will be used to guide future evidence-based guidelines regarding the evaluation of OSA in children. We will submit to the National Library of Medicine's PubMed Central an electronic version of the final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.

Locations

US (1)