OSA
Conditions
Brief summary
The aim of this evaluation is to test: 1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks 2. Patient mask type preferences at high pressures
Interventions
DEVICENasal mask
Nasal mask (Mirage Activa, Micro, FX)
DEVICEPillows mask
Nasal pillows mask (Swift FX)
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients willing to give written informed consent * Patients who can read and comprehend English * Patients being treated for OSA for \>6 months * Patients ≥ 18 years of age * Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O * Patients who can trial the trial masks up to 14 nights * Patients naive to pillows mask systems
Exclusion criteria
* Patients using an inappropriate mask system * Patients using Bilevel flow generators * Patients who are pregnant * Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AHI on Nasal Mask and Pillows Mask | 7 days | AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | After 7 days of use | Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good) |
Countries
Australia
Participant flow
Recruitment details
Participants recruited from ResMed Science Centre, Sydney, between Aug 2011 and Aug 2012
Participants by arm
| Arm | Count |
|---|---|
| Current CPAP Users Nasal mask; Pillows mask
Nasal mask : Nasal mask (Mirage Activa, Micro, FX)
Pillows mask : Nasal pillows mask (Swift FX) | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Current CPAP Users |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 64.6 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Australia | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
AHI on Nasal Mask and Pillows Mask
AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour
Time frame: 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Current CPAP Users | AHI on Nasal Mask and Pillows Mask | AHI on nasal mask | 1.7 events/hour | Standard Deviation 1.1 |
| Current CPAP Users | AHI on Nasal Mask and Pillows Mask | AHI on Nasal pillows | 1.9 events/hour | Standard Deviation 1.3 |
Secondary
Usability
Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)
Time frame: After 7 days of use
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Current CPAP Users | Usability | Subjective Scores Overall Performance-Nasal Mask | 8.0 Units on a scale |
| Current CPAP Users | Usability | Subjective Scores Overall Performance-Nasal Pillow | 8.5 Units on a scale |