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| ID | Type | Description | Link |
|---|---|---|---|
| MA07052013 | Other Identifier | Clinical Trial Notification (CTN) scheme, Therapeutic Goods Act (TGA), Australia |
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BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask.
The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time.
ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy.
AIMS
The aims of the study are:
It is hypothesised that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototype mask | Experimental | Participants will be randomised to trial the new prototype mask for 4 and 8 weeks. The prototype mask will be used in conjunction with the participant's home CPAP machine. The participant's will be instructed to use the prototype mask every night until the completion of the trial. No changes will be made to the participant's prescribed CPAP settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask - prototype | Device | prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks | The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial. | up to 8 weeks of use |
| Measure | Description | Time Frame |
|---|---|---|
| Measure and compare mask efficacy over a period of 8 weeks | The efficacy variables that will be measured and compared at each time point are: Apnea Hypopnea Index (AHI; the number of apneas and hypopneas per hour), mask leak, number of hours of use per night, and user compliance will be measured | After 2, 4, 6 and 8 weeks of use |
| Measure | Description | Time Frame |
|---|---|---|
| Measure and compare mask performance over a period of 8 weeks | Mask performance will be subjectively assessed by the user over a period of 8 weeks. Varibles which will be measured are:
| after 2, 4, 6 and 8 weeks of use |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed Ltd | 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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|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |