High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 11, 2017
January 1, 2017
1.5 years
January 9, 2017
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea Hypopnea Index (AHI)
Comparison of HFNC AHI to baseline AHI and to CPAP AHI
During at least 2 hours of sleep time
Secondary Outcomes (5)
Percent of hypoxemia time
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 Outcomes (3)
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
During at least 2 hours of sleep time
Study Arms (1)
High flow nasal cannula treatment
EXPERIMENTALAirvo 2 device will be used to administer high flow air during the night
Interventions
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mordechai R Kramer, MD
Pulmonary Institute, Rabin Medical Center, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pulmonary Institute
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 11, 2017
Study Start
January 1, 2017
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share