Recruiting

Home Apnea Testing

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05382754

Conditions

Sleep Apnea, Obstructive

Sleep Disorder

Sleep Apnea Syndromes

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Home sleep apnea test

In-lab polysomnography

Study Details

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

Study ID

NCT05382754

Start date

Mar 29, 2023

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

317 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: HSAT first

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

active comparator: PSG first

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

Interventions

Home sleep apnea test

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

In-lab polysomnography

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

Primary outcome measure

  • Proportion of participants with diagnosis of OSA on both HSAT and PSG [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Christopher M Cielo, DO

2674265748cieloc@chop.edu

Ignacio E Tapia, MD

305-243-9885itapia@miami.edu

Locations

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Yaelis Roman-Rosado

215-590-9184romanyd@chop.edu

Principal Investigator:

Christopher M Cielo, DO

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • obstructive sleep apnea
  • home sleep apnea testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-21.