Obstructive Sleep Apnea
Conditions
Keywords
Continuous Positive Airway Pressure
Brief summary
350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment. User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group). Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance
Interventions
DEVICEcontinuous positive airway pressure (CPAP)
CPAP comfort settings will be modified in the active group to be personalized to each participant
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing to give written informed consent * Patients who can read and comprehend English * Patients who are ≥ 18 years of age * Patients newly diagnosed with OSA and indicated for CPAP therapy.
Exclusion criteria
* Patients who have previously used PAP therapy * Patients who require a bilevel device * Patients who are or may be pregnant \* Patients who are unable to attend follow up appointments * Patients with a preexisting 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 * Patients believed to be unsuitable for inclusion by the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of treatment continuance between the control group and active treatment group. | 4 weeks after commencement of CPAP | Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of compliance between the control group and active treatment group | 4 weeks after commencement of CPAP | Usage will be compared between the two groups |
| Treatment efficacy | 4 weeks after commencement of CPAP | Residual Apnea-hypopnea index will be compared between the two groups |
| Settings changes | 4 weeks after commencement of CPAP | Number of comfort settings changes will be compared between the two groups |
| Ad hoc contacts | 4 weeks after commencement of CPAP | Number of ad hoc contacts between participants and clinicians will be compared between the two groups |
| Mask leak | 4 weeks after commencement of CPAP | Mask leak will be compared between the two groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory analysis of long term usage | 3,6,9, 12 months after commencement of CPAP | CPAP usage will be compared at 3, 6, 9 and 12 months for patients who have consented, as an exploratory analysis of long term usage |
Countries
Australia
Outcome results
None listed