High Flow Nasal Cannula for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
High flow nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continuous Positive Airway pressure, High Flow Nasal Cannula
Eligibility Criteria
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
Sites / Locations
- Sleep center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
First night HFNC group
First night CPAP group
Arm Description
The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.
In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Total Sleep Time
The total amount of sleep time spent during a study period.
Sleep Efficiency
Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03843372
Brief Title
High Flow Nasal Cannula for Obstructive Sleep Apnea
Official Title
High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chung-Chieh, Yu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Continuous Positive Airway pressure, High Flow Nasal Cannula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First night HFNC group
Arm Type
Experimental
Arm Description
The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.
Arm Title
First night CPAP group
Arm Type
Active Comparator
Arm Description
In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
continuous positive airway pressure
Intervention Description
All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
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
Title
Oxygen Desaturation Index
Description
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
Secondary Outcome Measure Information:
Title
Total Sleep Time
Description
The total amount of sleep time spent during a study period.
Time Frame
2 days
Title
Sleep Efficiency
Description
Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.
Time Frame
2days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sleep center
Organizational Affiliation
Chang-Gung Memorial Hospital, Keelung
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep center
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participants raw data will be made available.
IPD Sharing Time Frame
Data will available within 12 months of study completion
IPD Sharing Access Criteria
Requestors need application and explain the purpose. The data access will be provided after approved by review panel.
Citations:
PubMed Identifier
34145538
Citation
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.
Results Reference
derived
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High Flow Nasal Cannula for Obstructive Sleep Apnea
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