Obstructive Sleep ApneaNCT02858154
Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants
A study testing HFNC and Low flow oxygen by nasal cannula in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- HFNC and Low flow oxygen by nasal cannula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2016to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants ≤ 12 months
- Diagnosis of OSA from previous PSG
Who cannot join
- Infants who on previous PSG had central apneas > 50% of the AHI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Mercy Hospital
Kansas City, Kansas, 64108
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- HFNC, Low flow oxygen by nasal cannula
- Keywords
- OSA, obstructive sleep apnea, infants, high flow nasal cannula, HFNC
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCOther
Also called High Flow Nasal Cannula
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
| Study group | Role | What they receive |
|---|---|---|
| HFNC and low flow oxygen by nasal cannula | Other | 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) Receives: Other: HFNC; Other: Low flow oxygen by nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: end of visit (12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Responsible party
- Principal investigator, Neepa Gurbani, DO, Children's Hospital Medical Center, Cincinnati
- Investigators
- Neepa Gurbani, DO, Principal investigator, Children's Hospital Medical Center, CincinnatiZarmina Ehsan, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858154
- Sponsor's protocol ID
- CIN001-HFNC and OSA
- Status last verified
- Mar 2022
- First submitted
- 25 Jul 2016
- Last updated
- 15 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
PubMed 11331690Kotecha SJ, Adappa R, Gupta N, Watkins WJ, Kotecha S, Chakraborty M. Safety and Efficacy of High-Flow Nasal Cannula Therapy in Preterm Infants: A Meta-analysis. Pediatrics. 2015 Sep;136(3):542-53. doi: 10.1542/peds.2015-0738. Epub 2015 Aug 17.
PubMed 26283781Milesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014.
PubMed 25593745
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen (O2) as a Treatment for Obstructive Sleep Apnea (OSA) in Infants
- ClinicalTrials.gov ID
- NCT02858154
- Acronym / sponsor ID
- CIN001-HFNC and OSA
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, obstructive sleep apnea, infants, high flow nasal cannula, HFNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Children's Mercy Hospital Kansas City
- Study start
- Feb 2016
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNC and low flow oxygen by nasal cannula | Other | Other: HFNC, Other: Low flow oxygen by nasal cannulaAll 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) |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants ≤ 12 months
- Diagnosis of OSA from previous PSG
Key exclusion criteria (1 listed)
- Infants who on previous PSG had central apneas > 50% of the AHI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNCAlso: High Flow Nasal CannulaAll subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA | Other | HFNC and low flow oxygen by nasal cannula |
| Low flow oxygen by nasal cannulaAll 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 | Other | HFNC and low flow oxygen by nasal cannula |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11331690Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
- Background: PubMed 26283781Kotecha SJ, Adappa R, Gupta N, Watkins WJ, Kotecha S, Chakraborty M. Safety and Efficacy of High-Flow Nasal Cannula Therapy in Preterm Infants: A Meta-analysis. Pediatrics. 2015 Sep;136(3):542-53. doi: 10.1542/peds.2015-0738. Epub 2015 Aug 17.
- Background: PubMed 25593745Milesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neepa Gurbani, DO principal investigator
Children's Hospital Medical Center, Cincinnati
Zarmina Ehsan, MD principal investigator
Children's Mercy Hospital Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and Low flow oxygen by nasal cannula in people with Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC (time frame: End of visit (12 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858154, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.