High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03017859
• Other study ID #: RMC-16-0152
• Status: Not yet recruiting
• Phase: N/A
• First received: January 9, 2017
• Last updated: January 9, 2017
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Rabin Medical Center
• Contact: Avraham Unterman, MD
• Phone: 972-39377221
• Email: ramiun[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• High flow nasal cannula
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent rapid eye movement (REM) sleep		During at least 2 hours of sleep time	No
Other	Percent Deep sleep		During at least 2 hours of sleep time	No
Other	User experience with HFNC	To be assessed in the following morning with questionnaires	During at least 2 hours of sleep time	No
Primary	Apnea Hypopnea Index (AHI)	Comparison of HFNC AHI to baseline AHI and to CPAP AHI	During at least 2 hours of sleep time	No
Secondary	Percent of hypoxemia time	O2 saturation (SO2)<90% as measured by pulse oximeter	During at least 2 hours of sleep time	No
Secondary	Minimal SO2%		During at least 2 hours of sleep time	No
Secondary	Adverse events reported while using HFNC		During at least 2 hours of sleep time	No
Secondary	Sleep efficiency		During at least 2 hours of sleep time	No
Secondary	Total sleep time		During at least 2 hours of sleep time	No