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| ID | Type | Description | Link |
|---|---|---|---|
| CIA-356 | Other Identifier | Fisher and Paykel Healthcare |
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Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.
Participants are moved to the sleep laboratory for the night where they are provided with beds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive ventilation (CPAP or bilevel) with the investigational mask | Experimental |
| |
| Noninvasive ventilation (CPAP or bilevel) with the conventional mask | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Mask | Device | Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in respiratory rate | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Mereacre, PhD Physiology | Contact | 02102819036 | val.mereacre@fphcare.co.nz | |
| Jessica Fogarin | Contact | jess.fogarin@fphcare.co.nz |
| Name | Affiliation | Role |
|---|---|---|
| William Good, Medical degree | Middlemore Hospital, New Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher and Paykel Healthcare Sleep Laboratory | Auckland | 2013 | New Zealand |
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| Conventional mask | Device | Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy during sleep. |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D010845 | Obesity Hypoventilation Syndrome |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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