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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First night HFNC group | Experimental | 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 | Active Comparator | In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula | Device | All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 days |
| 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. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | The total amount of sleep time spent during a study period. | 2 days |
| Sleep Efficiency | Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sleep center | Chang Gung Memorial Hospital, Keelung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep center | Keelung | 204 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34145538 | Derived | Yu CC, Huang CY, Hua CC, Wu HP. High-flow nasal cannula compared with continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2022 Jun;26(2):549-558. doi: 10.1007/s11325-021-02413-0. Epub 2021 Jun 18. |
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De-identified participants raw data will be made available.
Data will available within 12 months of study completion
Requestors need application and explain the purpose. The data access will be provided after approved by review panel.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | First Night CPAP Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | events per hour | 2 days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP | The polysomnography data of 28 participants received one night CPAP therapy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Too strong airflow | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chung-Chieh Yu | Sleep Center, Chang Gung Memorial Hospital, Keelung, Taiwan | 886+22432-9292 | 2658 | terminatorchieh@yahoo.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2020 | Jun 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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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.
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|
| 2days |
The first night will receive continuous positive airway pressure(CPAP) and the second accept high flow nasal cannula(HFNC) therapy.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | BMI(body mass index) | Median | Inter-Quartile Range | kg/m^2 |
|
| Neck circumference | Median | Inter-Quartile Range | cm |
|
| AHI | Apnea hypopnea index (AHI) was represented by the number of apnea and hypopnea events per hour of sleep. An apnea is defined as a drop in the peak signal excursion by 90% of the pre-event baseline, and the duration of the 90% drop in sensor signal is 10 seconds. Events are considered hypopneas when the peak signal excursions drop by 30% of the pre-event baseline, and the duration of the 30% drop in signal excursion occurs for at least 10 seconds. Hypopneas are generally associated with a 3% oxygen desaturation or cause electroencephalogram arousal. | Median | Inter-Quartile Range | events per hour |
|
| DI | The desaturation index (DI) was the average number of desaturation episodes per hour. Desaturation episodes were defined as a decrease in the mean oxygen saturation of ≥3% from the pre-event baseline. | Median | Inter-Quartile Range | events per hour |
|
| Sleep efficiency | Sleep efficiency was the percentage of the total time spent asleep compared to the total amount of recording time. | Median | Inter-Quartile Range | % |
|
| Total sleep time | The total amount of sleep time spent during a study period. | Median | Inter-Quartile Range | minutes |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | events per hour | 2 days |
|
|
|
|
| Secondary | Total Sleep Time | The total amount of sleep time spent during a study period. | Posted | Median | Inter-Quartile Range | minutes | 2 days |
|
|
|
|
| Secondary | Sleep Efficiency | Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time. | Posted | Median | Inter-Quartile Range | percentage of sleep time | 2days |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 10 |
| 28 |
| EG001 | HFNC | The polysomnography data of 28 participants received one night HFNC therapy. | 0 | 28 | 0 | 28 | 24 | 28 |
| CPAP Mask or HFNC cannula discomfort | Product Issues | Systematic Assessment |
|
| Frequent awakenings | General disorders | Systematic Assessment |
|
| Too hot airflow | Product Issues | Systematic Assessment |
|
| Nasal stuffiness | General disorders | Systematic Assessment |
|
| dry nose or throat | General disorders | Systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |