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This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Headgear | Experimental | Investigative Headgear with CPAP mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigative Headgear with CPAP mask | Device | Investigative Headgear with CPAP mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reliability of the headgear using a Questionnaire | Assessment of headgear properties on a monthly basis via custom questionnaire via phone call | Monthly over a period of 6 months |
| Durability of the headgear by testing | Assessment of headgear properties on a monthly basis, and changes to the headgear | Monthly over a period of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Performance in regards to leak of the headgear | Objective Leak Data (L/min) from the device download | Monthly over a period of 6 months |
| Performance in regards to comfort of the headgear | Custom Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Gunson, BSc | Clinical Research Associate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare | Auckland | 2013 | New Zealand |
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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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| Monthly over a period of 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |