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

March 7, 2022 updated by: Neepa Gurbani, DO, Children's Hospital Medical Center, Cincinnati

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current standard of care for treating OSA in infants less than 6 months and frequently up to 12 months of age is with a continuous flow of oxygen by nasal cannula. This is generally referred to as nasal continuous positive airway pressure or NCPAP. A nasal cannula is used with oxygen at low flows of between 1/4 to 1 liter per minute (l/m) to deliver supplemental oxygen to reduce oxygen desaturations associated with apneic episodes and to provide a positive pressure flow to maintain an open airway.

High Flow Nasal Cannula (HFNC) therapy is a non-invasive treatment providing respiratory support. In this study, HFNC is designed to administer a heated and humidified mixture of air at a flow higher than the patient's inspiratory flow. There is currently no single, simple definition of high flow. In infants, it usually refers to a flow of >2 l/min and in children it is considered >6 l/min. High flow presents several advantages over conventional 'low-flow' oxygen therapy in terms of humidification, oxygenation, gas exchange, and breathing pattern. Several studies have shown that a flow higher than the patient's inspiratory flow provides better oxygen delivery than low-flow oxygen therapy or high-concentration oxygenation mask. This observation has been explained as the effect of a high flow on the oropharyngeal dead space, washing out oxygen depleted gas and reducing carbon dioxide (CO2) rebreathing. The extrathoracic dead space is proportionally two to three times greater in children than in adults. It may measure up to 3 mL/kg in newborns and becomes similar to the adult volume only after 6 years of age (0.8 mL/kg). Consequently, the younger a child is, the greater the effect of a high flow on oxygenation and CO2 clearance.

This pilot study is to compare standard of care low flow nasal oxygen to the effectiveness of HFNC therapy in infants aged 12 months and younger to treat OSA. The study intervention will occur for approximately 3 to 4 hours immediately prior to a scheduled clinical PSG. Subjects will be prepared for standard clinical PSG and after asleep, the intervention will be titration of room air at different pressure flows delivered by a HFNC system. At the end of the research portion of the PSG, the clinical PSG will begin with the standard of care treatment, the nasal oxygen titration for OSA. The results of the clinical PSG will serve as control comparison for the research intervention.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 64108
        • Children's Mercy Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HFNC and low flow oxygen by nasal cannula
All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive active comparator (low flow oxygen by nasal cannula)
Other: HFNC
All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA
Other Names:
  • High Flow Nasal Cannula
Other: Low flow oxygen by nasal cannula
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
Time Frame: End of visit (12 hours)
AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
End of visit (12 hours)
AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannula
Time Frame: end of visit (12 hours)
All subjects will receive 3-4 hours of experimental treatment (HFNC) during a research portion of a PSG and then for the 6-8 hours of clinically ordered PSG will receive low flow oxygen by nasal cannula.
end of visit (12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Neepa Gurbani, DO, Children's Hospital Medical Center, Cincinnati
  • Principal Investigator: Zarmina Ehsan, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

July 26, 2021

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN001-HFNC and OSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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