N/A
N=15
Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01846988 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Difference Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study — 7.3; 9.4 cmH2O
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- crossover treatment (REMstar Auto A-Flex) (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between Optimal Pressure (cm H2O) Derived From APAP run-in Period Versus Result of CPAP Titration Study |
7.3; 9.4 | — |
| PRIMARY Adherence Comparison of APAP vs.CPAP (% Days Device Used and % Days Device Used >4 Hours) |
62.5; 61.4; 42.7; 44.3 | — |
| SECONDARY Michigan Pediatric Sleep Questionnaire |
0.65; 0.44; 0.39 | — |
| SECONDARY Epworth Sleepiness Scale Questionnaire |
10.3; 7.6; 7.2 | — |
| SECONDARY Comparison of Pediatric Quality of Life Inventory Questionnaire Score Between Baseline and Each Randomization Period |
61.7; 65.9; 68.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 5 to 20 years of age
- apnea hypopnea index (AHI) of ≥5 or obstructive hypoventilation
Exclusion Criteria
- significant cranio-facial abnormalities
- chromosomal abnormalities that would affect compliance
- cerebral palsy
- significant neurological disease or neuromuscular disease
Data sourced from ClinicalTrials.gov (NCT01846988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.