Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.
Detailed description
It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).
Interventions
DEVICENasal and Oronasal PAP Mask
Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* AHI\> 30/hr * 18-75 years of age
Exclusion criteria
* History of claustrophobia * History of pacemaker, nerve stimulator, or any other metal implanted device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AHI | through study completion, an average of 1 hour | The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI of Upper Airway With Opposite PAP Mask | Approximately 1 hour | MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects-Nasal and Oronasal PAP Mask Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.
Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Subjects-Nasal and Oronasal PAP Mask |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
AHI
The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.
Time frame: through study completion, an average of 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline AHI | AHI | 42.3 events per hour | Standard Deviation 28.7 |
| Residual AHI | AHI | 1.58 events per hour | Standard Deviation 1.87 |
Secondary
MRI of Upper Airway With Opposite PAP Mask
MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.
Time frame: Approximately 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline AHI | MRI of Upper Airway With Opposite PAP Mask | 10 Participants |