An interventional study of HFNC and Low flow oxygen by nasal cannula in Obstructive Sleep Apnea, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 2 sites in United States. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 9 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 134 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
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Exclusion Criteria:
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 · Other: Low flow oxygen by nasal cannula
All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA
Also known as: High Flow 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
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)
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)
| Milestone | HFNC Followed by Clinically Ordered Low Flow Oxygen Via Nasal Cannula |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
| Milestone | HFNC Followed by Clinically Ordered Low Flow Oxygen Via Nasal Cannula |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
| events/hour | Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC |
|---|---|
| AHI on diagnostic study | 15.6 ± 5.65 |
| AHI with improvement in OSA with HFNC | 5.12 ± 2.5 |
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.
| events/hour | Average AHI Diagnostic Study Compared to Average AHI With Improvement in OSA With Low Flow Oxygen |
|---|---|
| AHI from diagnostic sleep study | 13.44 ± 5.36 |
| AHI from improvement in OSA with low flow oxygen by nasal cannula | 4.9 ± 3.12 |
Collected over 12 hours (duration of intervention). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HFNC for the First 3-4 Hours of the Study Followed by Clinically Ordered Low Flow Oxygen. | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula |
|---|---|
| <=18 years | 9 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula |
|---|---|
| Mean | 1.33 ± 1.73 |
| Sex: Female, Male(Participants) | Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula |
|---|---|
| Female | 4 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula |
|---|
| Region of Enrollment(participants) | Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula |
|---|---|
| United States | 9 |
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