Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
Public ClinicalTrials.gov record NCT01846988. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy of Auto-adjustable Positive Airway Pressure (APAP) in Pediatric Patients With Obstructive Sleep Apnea (OSA).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children. APAP is a device similar to continuous positive airway pressure (CPAP) that delivers pressure to the upper airway (nose and throat) to keep the airway from collapsing while during sleep. The difference is that APAP adjusts the pressure throughout the night with changes in resistance during breathing, and CPAP gives the same amount of pressure the whole time it is worn. APAP is currently widely used to treat adults with OSA, however, this device has not yet been extensively studied in children. There are two parts to this research study. Subjects will begin using APAP at the time of enrollment for 4 to 8 weeks. The investigators will compare the pressure measured by the APAP device over the 4-8 weeks with the pressure determined by a CPAP titration study. The titration study is a second overnight sleep study that is routinely ordered when a child with sleep apnea starts treatment with CPAP. It tells the doctor what CPAP setting should be used. In the second part of this study The investigators will compare the effects of APAP with CPAP to see what is reported as more comfortable and is used during more hours of sleep. This part of the study will last about 8 weeks and each subject will use both CPAP and APAP for 4 weeks each. Currently when someone is diagnosed with OSA there is a delay in starting treatment with CPAP until the results of the titration study are available. In this research, patients could be allowed to immediately start treatment with APAP. If APAP is found to be as safe and effective as regular CPAP, treatment with APAP could be used as an alternative to CPAP.
Study identification
- NCT ID
- NCT01846988
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2012
- Primary completion
- Nov 30, 2018
- Completion
- Aug 31, 2019
- Last update posted
- Apr 22, 2021
2012 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01846988, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 22, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01846988 live on ClinicalTrials.gov.