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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Default comfort settings | Active Comparator | Comfort settings will be set to default (out of the box setttings) |
|
| Personalized Therapy Comfort Settings | Experimental | Comfort settings will be personalized to each user |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous positive airway pressure (CPAP) | Device | CPAP comfort settings will be modified in the active group to be personalized to each participant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of treatment continuance between the control group and active treatment group. | Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment. | 4 weeks after commencement of CPAP |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of compliance between the control group and active treatment group | Usage will be compared between the two groups | 4 weeks after commencement of CPAP |
| Treatment efficacy | Residual Apnea-hypopnea index will be compared between the two groups |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory analysis of long term usage | 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 | 3,6,9, 12 months after commencement of CPAP |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Armitstead, PhD | ResMed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed Centre for Healthy Sleep | Bella Vista | New South Wales | 2153 | Australia |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| 4 weeks after commencement of CPAP |
| Mask leak | Mask leak will be compared between the two groups | 4 weeks after commencement of CPAP |
| Settings changes | Number of comfort settings changes will be compared between the two groups | 4 weeks after commencement of CPAP |
| Ad hoc contacts | Number of ad hoc contacts between participants and clinicians will be compared between the two groups | 4 weeks after commencement of CPAP |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |