Back to resultsEffect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
High Flow Nasal Cannula (HFNC)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Adults patient aging above 18 years
- Diagnosed with Obstructive Sleep Apnea (OSA) based on Polysomnography (PSG) ranging from mild to severe i.e. more than 5
Exclusion Criteria:
- Patients with hypoventilation syndrome
- Patients with chronic obstructive pulmonary disease
- Patients who have unstable hemodynamic state, who experienced intolerance to HFNC or CPAP
- Patients who are pregnant
- Patients recently underwent surgery
Sites / Locations
- King Abdulaziz University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants diagnosed with Obstructive Sleep Apnea
Arm Description
The participants will sleep three nights at the sleep lab and undergo in their first night, Polysomnography (PSG). Then at random, some of them will do CPAP titration in the second night followed by HFNC titration in the third night. While others will do HFNC titration in the second night followed by CPAP titration in the third night
Outcomes
Primary Outcome Measures
Apnea/Hypopnea Index count using High Flow Nasal Cannula oxygen device and Continuous Positive Pressure Airway device on patients with Obstructive Sleep Apnea
the Apnea/Hypopnea Index (AHI) is 5 events or less
Sleep architecture while using High Flow Nasal Cannula oxygen device
Standard sleep architecture: sleep breathing disorder e.g. apnea, hypopnea, snoring Oxygenation : minimum oxygen saturation, duration of desaturation and number of desaturation Arousals : number and index
Tolerance and acceptability of High Flow Nasal Cannula by patients compared to the standard Continuous Positive Airway Pressure
Comparison of High Flow Nasal Cannula device compared to the Continuous Positive Airway Pressure for a long term usage; being assessed in
How well did you accept the device yesterday?
How comfortable was the usage of the device?
Was the used mask comfortable? (1)not acceptable, (2)tolerable, (3)acceptable, (4)well received, (5)excellent
Did you face any difficulties breathing through your nose while using the device last night?
Did you have any of these symptoms while using the mask last night? Nasal dryness, Mouth dryness, Runny nose, Fear or anxiety, Congested nose
Did you feel any air leakage from the mask last night ?
Was it hard keeping the mask on while sleeping?
Are you prepared to use the CPAP machine as a therapy daily?
Secondary Outcome Measures
Changes in sleep structure compared to the diagnostic night
Refine the sleep structure with the usage of the device, the count of Apnea/Hypopnea index, number of arousals, number of desaturations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05475119
Brief Title
Effect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea
Official Title
Effect of High Flow Nasal Cannula (HFNC) Versus Continues Positive Airway Pressure (CPAP) in Adults With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The participants whom undergo Polysomnography study (Sleep study) and are found to have mild, moderate or severe Obstructive Sleep Apnea (OSA) will have two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.
Detailed Description
The participants undergo three nights in the Sleep Lab. In their first night they perpetrate Polysomnography study (Sleep study) and then classifies to have mild, moderate or severe Obstructive Sleep Apnea (OSA) or not. Those who are diagnosed with OSA, will undergo two consecutive titration nights. Randomly, they'll do (CPAP) titration followed by (HFNC) titration or vice versa. To explore the possibility of the CPAP not being superior to HFNC in reduction of sleep apnea events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants diagnosed with Obstructive Sleep Apnea
Arm Type
Experimental
Arm Description
The participants will sleep three nights at the sleep lab and undergo in their first night, Polysomnography (PSG). Then at random, some of them will do CPAP titration in the second night followed by HFNC titration in the third night. While others will do HFNC titration in the second night followed by CPAP titration in the third night
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
Continuous Positive Airway Pressure (CPAP) is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of an individual.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula (HFNC)
Intervention Description
High Flow Nasal Cannula (HFNC) is an oxygen supply system capable of delivering up to 100% humidified and heated oxygen at a flow rate of up to 60 liters per minute
Primary Outcome Measure Information:
Title
Apnea/Hypopnea Index count using High Flow Nasal Cannula oxygen device and Continuous Positive Pressure Airway device on patients with Obstructive Sleep Apnea
Description
the Apnea/Hypopnea Index (AHI) is 5 events or less
Time Frame
two nights
Title
Sleep architecture while using High Flow Nasal Cannula oxygen device
Description
Standard sleep architecture: sleep breathing disorder e.g. apnea, hypopnea, snoring Oxygenation : minimum oxygen saturation, duration of desaturation and number of desaturation Arousals : number and index
Time Frame
two nights
Title
Tolerance and acceptability of High Flow Nasal Cannula by patients compared to the standard Continuous Positive Airway Pressure
Description
Comparison of High Flow Nasal Cannula device compared to the Continuous Positive Airway Pressure for a long term usage; being assessed in
How well did you accept the device yesterday?
How comfortable was the usage of the device?
Was the used mask comfortable? (1)not acceptable, (2)tolerable, (3)acceptable, (4)well received, (5)excellent
Did you face any difficulties breathing through your nose while using the device last night?
Did you have any of these symptoms while using the mask last night? Nasal dryness, Mouth dryness, Runny nose, Fear or anxiety, Congested nose
Did you feel any air leakage from the mask last night ?
Was it hard keeping the mask on while sleeping?
Are you prepared to use the CPAP machine as a therapy daily?
Time Frame
two nights
Secondary Outcome Measure Information:
Title
Changes in sleep structure compared to the diagnostic night
Description
Refine the sleep structure with the usage of the device, the count of Apnea/Hypopnea index, number of arousals, number of desaturations
Time Frame
two night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults patient aging above 18 years
Diagnosed with Obstructive Sleep Apnea (OSA) based on Polysomnography (PSG) ranging from mild to severe i.e. more than 5
Exclusion Criteria:
Patients with hypoventilation syndrome
Patients with chronic obstructive pulmonary disease
Patients who have unstable hemodynamic state, who experienced intolerance to HFNC or CPAP
Patients who are pregnant
Patients recently underwent surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siraj O Wali, Professor
Phone
0126408222
Ext
16045
Email
sowali@kau.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siraj O Wali, Professor
Organizational Affiliation
Teaching Assistant at King Abdulaziz University
Official's Role
Study Director
Facility Information:
Facility Name
King Abdulaziz University Hospital
City
Jeddah
State/Province
Western
ZIP/Postal Code
22230
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siraj O Wali, Professor
Phone
0126408222
Ext
1640
Email
sowali@kau.edu.sa
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study outcome might be shared as well as the methodology
Learn more about this trial
Effect of High Flow Nasal Cannula Versus Continues Positive Airway Pressure in Adults With Obstructive Sleep Apnea
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