High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

Not Applicable

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: High flow nasal cannula

• Registration Number: NCT03017859
• Lead Sponsor: Rabin Medical Center

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 Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High flow nasal cannula treatment	High flow nasal cannula	Airvo 2 device will be used to administer high flow air during the night

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	During at least 2 hours of sleep time	Comparison of HFNC AHI to baseline AHI and to CPAP AHI

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency	During at least 2 hours of sleep time
Percent of hypoxemia time	During at least 2 hours of sleep time	O2 saturation (SO2)\<90% as measured by pulse oximeter
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