Back to resultsHigh Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High flow nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 years
- Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
- Apnea Hypopnea Index (AHI)≥15
- Patient has difficulties to adjust or comply with CPAP treatment
- Signed Informed Consent Form
Exclusion Criteria:
- Patients who need bilevel positive airway pressure (BIPAP)
- Known carbon dioxide (CO2) retainers
- Weight change>10% compared to time of OSA diagnosis
- Clinically unstable patients
- Pregnant women or special populations (e.g. children or patients unable to give informed consent)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High flow nasal cannula treatment
Arm Description
Airvo 2 device will be used to administer high flow air during the night
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (AHI)
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
Secondary Outcome Measures
Percent of hypoxemia time
O2 saturation (SO2)<90% as measured by pulse oximeter
Minimal SO2%
Adverse events reported while using HFNC
Sleep efficiency
Total sleep time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03017859
Brief Title
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Official Title
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.
Detailed Description
A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula treatment
Arm Type
Experimental
Arm Description
Airvo 2 device will be used to administer high flow air during the night
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Description
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
Time Frame
During at least 2 hours of sleep time
Secondary Outcome Measure Information:
Title
Percent of hypoxemia time
Description
O2 saturation (SO2)<90% as measured by pulse oximeter
Time Frame
During at least 2 hours of sleep time
Title
Minimal SO2%
Time Frame
During at least 2 hours of sleep time
Title
Adverse events reported while using HFNC
Time Frame
During at least 2 hours of sleep time
Title
Sleep efficiency
Time Frame
During at least 2 hours of sleep time
Title
Total sleep time
Time Frame
During at least 2 hours of sleep time
Other Pre-specified Outcome Measures:
Title
Percent rapid eye movement (REM) sleep
Time Frame
During at least 2 hours of sleep time
Title
Percent Deep sleep
Time Frame
During at least 2 hours of sleep time
Title
User experience with HFNC
Description
To be assessed in the following morning with questionnaires
Time Frame
During at least 2 hours of sleep time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-80 years
Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years
Apnea Hypopnea Index (AHI)≥15
Patient has difficulties to adjust or comply with CPAP treatment
Signed Informed Consent Form
Exclusion Criteria:
Patients who need bilevel positive airway pressure (BIPAP)
Known carbon dioxide (CO2) retainers
Weight change>10% compared to time of OSA diagnosis
Clinically unstable patients
Pregnant women or special populations (e.g. children or patients unable to give informed consent)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avraham Unterman, MD
Phone
972-39377221
Email
ramiun@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Organizational Affiliation
Pulmonary Institute, Rabin Medical Center, Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
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