Obstructive Sleep Apnea (OSA)
Conditions
Brief summary
Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.
Interventions
DEVICESwitch CPAP mask type
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * previously diagnosed with OSA * returning for PAP titrations at the Center for Sleep Medicine * CPAP and titration naive * Must have a Apnea/Hypopnea Index (AHI) of ≥ 16/hr.
Exclusion criteria
* Patients with ≥ 50% central apneas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | 3 weeks for each mask condition | Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oronasal Mask Initial administration of oronasal CPAP mask
Switch CPAP mask type | 12 |
| Nasal Mask Initial administration of nasal CPAP mask
Switch CPAP mask type | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Nasal Mask | Total | Oronasal Mask |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 20 Participants | 11 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 19 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks
Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.
Time frame: 3 weeks for each mask condition
Population: higher values represent a better outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Sleep Time - Nasal Mask | Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | 332.64 minutes | Standard Deviation 92.09 |
| Total Sleep Time (TST) Oronasal Mask | Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | 346.79 minutes | Standard Deviation 86.74 |