Sleep Apnea, Obstructive
Conditions
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.
Interventions
DEVICEHigh flow nasal cannula
We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | During at least 2 hours of sleep time | Comparison of HFNC AHI to baseline AHI and to CPAP AHI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Sleep efficiency | During at least 2 hours of sleep time | — |
| Total sleep time | During at least 2 hours of sleep time | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| User experience with HFNC | During at least 2 hours of sleep time | To be assessed in the following morning with questionnaires |
| Percent Deep sleep | During at least 2 hours of sleep time | — |
| Percent rapid eye movement (REM) sleep | During at least 2 hours of sleep time | — |
Contacts
Primary ContactAvraham Unterman, MD
Outcome results
None listed