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Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New generation CPAP mask | Experimental | The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New generation CPAP mask | Device | All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (event/hour) | Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study | up to 90 days |
| Usage Hours (hours/night) | Average usage hours taken from the participant's CPAP device used during the study | up to 90 days |
| Leak (L/minute) | Calculated leak from CPAP machine which assess how well mask seals on patients | up to 90 days |
| CPAP Pressure (cmH2O) | Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open | up to 90 days |
| Adverse Events | Device related adverse events during the study period will also be assessed. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| General Usability | Subjective usability scores from participants. Each usability item of the new mask system will be rated on a Likert Scale questionnaire. A score of 10 is considered very favourable whereas score of 0 is considered very unfavourable. | up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueling Zhu, BHSc (Nursing), RN | Contact | 02 8884 2265 | Xueling.Zhu@resmed.com.au | |
| Ross Deas, PhD | Contact | 02 8884 1703 | ross.deas@resmed.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Jeff Armistead, PhD | ResMed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affairs ResMed | Recruiting | Sydney | New South Wales | 2153 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39498349 | Derived | Zhu X, Benjafield A, Deas R, Willes L, Armitstead J. Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care. Sleep Med X. 2024 Oct 11;8:100128. doi: 10.1016/j.sleepx.2024.100128. eCollection 2024 Dec 15. |
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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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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |