Trial Outcomes & Findings for High Flow Nasal Cannula for Obstructive Sleep Apnea (NCT NCT03843372)
NCT ID: NCT03843372
Last Updated: 2020-12-17
Results Overview
The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
2 days
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
HFNC First, Then CPAP
Participants first received high flow nasal cannula (HFNC) for one night. After a washout period of one week, they then received continuous positive airway pressure (CPAP) for one night.
|
CPAP First, Then HFNC
Participants first received continuous positive airway pressure (CPAP) for one night. After a washout period of one week, they then received high flow nasal cannula (HFNC) for one night.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Flow Nasal Cannula for Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
First Night HFNC Group
n=12 Participants
The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.
|
First Night CPAP Group
n=16 Participants
The first night will receive continuous positive airway pressure(CPAP) and the second accept high flow nasal cannula(HFNC) therapy.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
53.5 years
n=7 Participants
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
BMI
|
30.1 kg/m^2
n=5 Participants
|
26.95 kg/m^2
n=7 Participants
|
27.4 kg/m^2
n=5 Participants
|
|
Neck circumference
|
41.5 cm
n=5 Participants
|
37.5 cm
n=7 Participants
|
38.5 cm
n=5 Participants
|
|
AHI
|
51.65 events per hour
n=5 Participants
|
26.9 events per hour
n=7 Participants
|
34.9 events per hour
n=5 Participants
|
|
DI
|
45.15 events per hour
n=5 Participants
|
24.45 events per hour
n=7 Participants
|
29.4 events per hour
n=5 Participants
|
|
Sleep efficiency
|
80.7 %
n=5 Participants
|
80.4 %
n=7 Participants
|
80.4 %
n=5 Participants
|
|
Total sleep time
|
324 minutes
n=5 Participants
|
331.65 minutes
n=7 Participants
|
330.15 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysThe Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Outcome measures
| Measure |
CPAP
n=28 Participants
The polysomnography data of 28 participants treated with one night CPAP.
|
HFNC
n=28 Participants
The polysomnography data of 28 participants received one night HFNC therapy.
|
|---|---|---|
|
Apnea Hypopnea Index
|
6.15 events per hour
Interval 2.63 to 8.28
|
14.85 events per hour
Interval 6.85 to 27.3
|
PRIMARY outcome
Timeframe: 2 daysThe oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.
Outcome measures
| Measure |
CPAP
n=28 Participants
The polysomnography data of 28 participants treated with one night CPAP.
|
HFNC
n=28 Participants
The polysomnography data of 28 participants received one night HFNC therapy.
|
|---|---|---|
|
Oxygen Desaturation Index
|
1.25 events per hour
Interval 0.4 to 4.0
|
5.25 events per hour
Interval 2.08 to 21.55
|
SECONDARY outcome
Timeframe: 2 daysThe total amount of sleep time spent during a study period.
Outcome measures
| Measure |
CPAP
n=28 Participants
The polysomnography data of 28 participants treated with one night CPAP.
|
HFNC
n=28 Participants
The polysomnography data of 28 participants received one night HFNC therapy.
|
|---|---|---|
|
Total Sleep Time
|
343 minutes
Interval 333.25 to 366.5
|
292.75 minutes
Interval 265.63 to 325.0
|
SECONDARY outcome
Timeframe: 2daysSleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.
Outcome measures
| Measure |
CPAP
n=28 Participants
The polysomnography data of 28 participants treated with one night CPAP.
|
HFNC
n=28 Participants
The polysomnography data of 28 participants received one night HFNC therapy.
|
|---|---|---|
|
Sleep Efficiency
|
86.1 percentage of sleep time
Interval 80.15 to 90.43
|
74.25 percentage of sleep time
Interval 65.8 to 80.75
|
Adverse Events
CPAP
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HFNC
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPAP
n=28 participants at risk
The polysomnography data of 28 participants received one night CPAP therapy.
|
HFNC
n=28 participants at risk
The polysomnography data of 28 participants received one night HFNC therapy.
|
|---|---|---|
|
Product Issues
Too strong airflow
|
0.00%
0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
17.9%
5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
|
Product Issues
CPAP Mask or HFNC cannula discomfort
|
21.4%
6/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
3.6%
1/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
|
General disorders
Frequent awakenings
|
7.1%
2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
17.9%
5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
|
Product Issues
Too hot airflow
|
0.00%
0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
17.9%
5/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
|
General disorders
Nasal stuffiness
|
0.00%
0/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
21.4%
6/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
|
General disorders
dry nose or throat
|
7.1%
2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
7.1%
2/28 • 2 days; All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
CPAP and HFNC have been widely used in clinical practice for long time, but the serious adverse effects or mortality events are rarely reported . Our study excluded the participants who have unstable clinical condition. Therefore, there was no serious adverse events or mortality in our study.
|
Additional Information
Dr. Chung-Chieh Yu
Sleep Center, Chang Gung Memorial Hospital, Keelung, Taiwan
Phone: 886+22432-9292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place