Trial Outcomes & Findings for Comparison of High Flow Nasal Cannula Therapy to Nasal Oxygen as a Treatment for Obstructive Sleep Apnea in Infants (NCT NCT02858154)
NCT ID: NCT02858154
Last Updated: 2022-03-15
Results Overview
AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
End of visit (12 hours)
Results posted on
2022-03-15
Participant Flow
Participant milestones
| Measure |
HFNC Followed by Clinically Ordered Low Flow Oxygen Via Nasal Cannula
All subjects received HFNC followed by clinically ordered low flow oxygen via nasal cannula.
HFNC: All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA
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 in infants) to control sleep apnea and desaturations
|
|---|---|
|
HFNC 3-4 Hours
STARTED
|
9
|
|
HFNC 3-4 Hours
COMPLETED
|
9
|
|
HFNC 3-4 Hours
NOT COMPLETED
|
0
|
|
Clinically Ordered PSG/Low Flow Oxygen
STARTED
|
9
|
|
Clinically Ordered PSG/Low Flow Oxygen
COMPLETED
|
9
|
|
Clinically Ordered PSG/Low Flow Oxygen
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Children With OSA Receiving HFNC and Low Flow Oxygen With Nasal Cannula
n=9 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
1.33 months
STANDARD_DEVIATION 1.73 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: End of visit (12 hours)Population: We analyzed subjects who had improvement in AHI with HFNC compared to the diagnostic study.
AHI will be compared from diagnostic sleep study to average AHI with improvement in OSA with HFNC
Outcome measures
| Measure |
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
n=4 Participants
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.
|
|---|---|
|
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
AHI on diagnostic study
|
15.6 events/hour
Standard Deviation 5.65
|
|
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
AHI with improvement in OSA with HFNC
|
5.12 events/hour
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: end of visit (12 hours)Population: Compared AHI with low flow oxygen via nasal cannula compared to diagnostic sleep study AHI.
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.
Outcome measures
| Measure |
Average AHI Diagnostic Sleep Study Compared to Average AHI With Improvement in OSA With HFNC
n=9 Participants
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.
|
|---|---|
|
AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannula
AHI from diagnostic sleep study
|
13.44 events/hour
Standard Deviation 5.36
|
|
AHI From Diagnostic Sleep Study Compared to AHI From Sleep Study Improvement in OSA With Low Flow Oxygen Via Nasal Cannula
AHI from improvement in OSA with low flow oxygen by nasal cannula
|
4.9 events/hour
Standard Deviation 3.12
|
Adverse Events
HFNC for the First 3-4 Hours of the Study Followed by Clinically Ordered Low Flow Oxygen.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Neepa Gurbani
Cincinnati Children's Hospital Medical Center
Phone: 513-736-1814
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place