High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: High flow nasal cannula

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avraham Unterman, MD; Phone Number: 972-39377221; Email: ramiun@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent rapid eye movement (REM) sleep		During at least 2 hours of sleep time
Percent Deep sleep		During at least 2 hours of sleep time
User experience with HFNC	To be assessed in the following morning with questionnaires	During at least 2 hours of sleep time

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Mordechai R Kramer, MD, Pulmonary Institute, Rabin Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: RMC-16-0152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No