Obstructive Sleep Apnea
Conditions
Keywords
Continuous Positive Airway pressure, High Flow Nasal Cannula
Brief summary
This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.
Detailed description
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness. Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy. All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.
Interventions
DEVICEHigh flow nasal cannula
All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.
Sponsors
Chung-Chieh, Yu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All of participants will be randomly allocated into two groups as random number table. The first group will ongoing CPAP therapy in first night and high flow nasal cannula in the second night. The second group will oppositely performed high flow nasal cannula in first night and CPAP in second night.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Apnea hypopnea index greater than 5 times per hour * Age greater than 18 years old.
Exclusion criteria
* Central sleep apnea * Hypoventilation syndrome * Chronic obstructive airway disease * Receive soft palate surgery or used an oral appliance * Intolerance to transnasal high flow or CPAP * Pregnant women * Unstable hemodynamic state * Eastern Cooperative Oncology Group Performance Status higher than grade 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | 2 days | 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. |
| Oxygen Desaturation Index | 2 days | The 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | 2 days | The total amount of sleep time spent during a study period. |
| Sleep Efficiency | 2days | Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| First Night HFNC Group The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy. | 12 |
| First Night CPAP Group The first night will receive continuous positive airway pressure(CPAP) and the second accept high flow nasal cannula(HFNC) therapy. | 16 |
| Total | 28 |
Baseline characteristics
| Characteristic | First Night CPAP Group | Total | First Night HFNC Group |
|---|---|---|---|
| Age, Continuous | 53.5 years | 53.5 years | 53.5 years |
| AHI | 26.9 events per hour | 34.9 events per hour | 51.65 events per hour |
| BMI | 26.95 kg/m^2 | 27.4 kg/m^2 | 30.1 kg/m^2 |
| DI | 24.45 events per hour | 29.4 events per hour | 45.15 events per hour |
| Neck circumference | 37.5 cm | 38.5 cm | 41.5 cm |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 28 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 16 participants | 28 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
| Sleep efficiency | 80.4 % | 80.4 % | 80.7 % |
| Total sleep time | 331.65 minutes | 330.15 minutes | 324 minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 10 / 28 | 24 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Apnea Hypopnea Index
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.
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Apnea Hypopnea Index | 6.15 events per hour |
| HFNC | Apnea Hypopnea Index | 14.85 events per hour |
Comparison: The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNCp-value: <0.001Wilcoxon rank sum test
Primary
Oxygen Desaturation Index
The 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.
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Oxygen Desaturation Index | 1.25 events per hour |
| HFNC | Oxygen Desaturation Index | 5.25 events per hour |
Comparison: The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNCp-value: <0.001Wilcoxon rank sum test
Secondary
Sleep Efficiency
Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.
Time frame: 2days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Sleep Efficiency | 86.1 percentage of sleep time |
| HFNC | Sleep Efficiency | 74.25 percentage of sleep time |
Comparison: The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNCp-value: 0.008Wilcoxon rank sum test
Secondary
Total Sleep Time
The total amount of sleep time spent during a study period.
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CPAP | Total Sleep Time | 343 minutes |
| HFNC | Total Sleep Time | 292.75 minutes |
Comparison: The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNCp-value: <0.001Wilcoxon rank sum test