High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 30
- Primary Endpoint
- Apnea Hypopnea Index (AHI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
High flow nasal cannula treatment
Airvo 2 device will be used to administer high flow air during the night
Intervention: High flow nasal cannula (Device)
Outcomes
Primary Outcomes
Apnea Hypopnea Index (AHI)
Time Frame: During at least 2 hours of sleep time
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
Secondary Outcomes
- Percent of hypoxemia time(During at least 2 hours of sleep time)
- Sleep efficiency(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)
- Total sleep time(During at least 2 hours of sleep time)
Investigators
Mordechai Kremer
Head of Pulmonary Institute
Rabin Medical Center