Home Apnea Testing in CHildren Trial

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05382754
Status
Recruiting
Apply to this trial

Conditions

  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive
  • Sleep Disorder
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

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.
  • In-lab polysomnography — DIAGNOSTIC_TEST
    Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Study Details

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.

Key Dates

Start date
Mar 29, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
317 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Yaelis Roman-Rosado
[email protected]
215-590-9184
Christopher M Cielo, DO (PRINCIPAL_INVESTIGATOR)
Ignacio E Tapia, MD (SUB_INVESTIGATOR)

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By research site
The Children's Hospital of Philadelphia· Philadelphia, PA

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