High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: High flow nasal cannula


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow nasal cannula treatment<br>Airvo 2 device will be used to administer high flow air during the night | Device: High flow nasal cannula<br>* We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) | Comparison of HFNC AHI to baseline AHI and to CPAP AHI | During at least 2 hours of sleep time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of hypoxemia time | O2 saturation (SO2)<90% as measured by pulse oximeter | During at least 2 hours of sleep time | 
| Minimal SO2% |  | During at least 2 hours of sleep time | 
| Adverse events reported while using HFNC |  | During at least 2 hours of sleep time | 
| Sleep efficiency |  | During at least 2 hours of sleep time | 
| Total sleep time |  | During at least 2 hours of sleep time |