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As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A_ washing procedure 1 | Experimental | This group will apply washing technique 1. |
|
| Group B_washing procedure 2 | Experimental | This group will apply washing technique 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask | Device | A new vent CPAP mask system will be used in this trial. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The apnoea/hypopnoea index (AHI) will be recorded and analysed. | Breathing disruption events per hour of sleep will be measured and analysed | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The level of comfort patients experience while using the new mask vent | Patients will complete a questionnaire regarding the noise of the new vent | 12 weeks |
| Patient's and bed partner's perceptions of the mask vent |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are pregnant
Patient on bi level treatment
Patients being treated for OSA < 6 months
Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (<2 years ago) case of pneumonia or lung infection; lung injury).
Patients who are deemed unsuitable by the researcher due to the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, PhD | ResMed/ The University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed Centre for Healthy Sleep | Sydney | 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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| CPAP mask |
| Device |
A new vent CPAP mask system will be used in this trial |
|
Patients partners will complete a questionnaire regarding the noise of the mask vent
| 12 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |