N/A
N=9
Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02858154 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC — 15.6; 5.12 events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HFNC (Other); Low flow oxygen by nasal cannula (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC |
15.6; 5.12 | — |
| PRIMARY AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannula |
13.44; 4.9 | — |
Summary
This is a small pilot study that will compare High Flow Nasal Cannula (HFNC) therapy to oxygen nasal cannula therapy on infants who have obstructive sleep apnea (OSA) and are scheduled for a clinically ordered sleep study called polysomnography (PSG). The HFNC procedure uses humidified room air delivered by nasal cannula at higher pressures and will test if HFNC can control OSA in infants better or as well as low flow nasal oxygen, the current clinical standard of care. All the infants in the study will have a brief test period of about 3 to 4 hours with the HFNC before participants begin their standard clinical PSG for titration of oxygen by nasal cannula for treatment of OSA.
Eligibility Criteria
Inclusion Criteria
- Infants ≤ 12 months
- Diagnosis of OSA from previous PSG
Exclusion Criteria
- Infants who on previous PSG had central apneas > 50% of the AHI
Data sourced from ClinicalTrials.gov (NCT02858154). 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.