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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02858154
Enrollment
9
Registered
2016-08-08
Start date
2016-02-29
Completion date
2021-07-26
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

OSA, obstructive sleep apnea, infants, high flow nasal cannula, HFNC

Brief 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.

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.

Interventions

OTHERHFNC

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

OTHERLow 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

Sponsors

Children's Mercy Hospital Kansas City
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCEnd of visit (12 hours)AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannulaend 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Children With OSA Receiving HFNC and Low Flow Oxygen With 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 (oxygen by nasal cannula) HFNC: All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA Oxygen by 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 control sleep apnea and desaturations
9
Total9

Baseline characteristics

CharacteristicChildren With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula
Age, Categorical
<=18 years
9 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous1.33 months
STANDARD_DEVIATION 1.73
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 9
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via 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 low flow oxygen by nasal cannula.

Time frame: end of visit (12 hours)

Population: Compared AHI with low flow oxygen via nasal cannula compared to diagnostic sleep study AHI.

ArmMeasureGroupValue (MEAN)Dispersion
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal CannulaAHI from diagnostic sleep study13.44 events/hourStandard Deviation 5.36
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal CannulaAHI from improvement in OSA with low flow oxygen by nasal cannula4.9 events/hourStandard Deviation 3.12
Primary

Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC

AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC

Time frame: End of visit (12 hours)

Population: We analyzed subjects who had improvement in AHI with HFNC compared to the diagnostic study.

ArmMeasureGroupValue (MEAN)Dispersion
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAverage AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAHI on diagnostic study15.6 events/hourStandard Deviation 5.65
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAverage AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNCAHI with improvement in OSA with HFNC5.12 events/hourStandard Deviation 2.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026