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NCT01846988 · ClinicalTrials.gov registry record · NA
Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01846988 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants.
The verdict
NCT01846988, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE crossover treatment (REMstar Auto A-Flex)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-10 |
| Est. Completion | 2019-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01846988
The ClinicalTrials.gov registry entry for NCT01846988 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which crossover treatment (REMstar Auto A-Flex) is the first listed.
NCT01846988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01846988 about?
NCT01846988 is a clinical study titled "Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea". 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 th...
What is the current status of trial NCT01846988?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2012-10. Estimated completion is 2019-09-01.
What interventions are being tested in trial NCT01846988?
The interventions under investigation include: crossover treatment (REMstar Auto A-Flex) (DEVICE).
Who is sponsoring clinical trial NCT01846988?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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