CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
HFNC +1 moreother
Likely dose
HFNC for 3-4 hours; low-flow oxygen by nasal cannula for 6-8 hours during clinically scheduled PSG titrationAI-extracted
Key inclusion· 2
  • Age 12 months or younger
  • Diagnosis of obstructive sleep apnea confirmed by prior polysomnography
Key exclusion· 1
  • Central apneas comprising >50% of the apnea-hypopnea index on previous PSG

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02858154
NCT02858154N/ACompleted

Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen (O2) as a Treatment for Obstructive Sleep Apnea (OSA) in Infants

Children's Hospital Medical Center, Cincinnati·interventional·Posted Aug 8, 2016·Updated Mar 15, 2022

In Brief

A clinical study evaluating HFNC and Low flow oxygen by nasal cannula for Obstructive Sleep Apnea. Completed, enrolled 9 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 8, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 26, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.9 years ago

Interventions

HFNCother

All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA

Low flow oxygen by nasal cannulaother

All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care) to manage sleep apnea