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Trial was terminated by investigators due to equipment difficulties
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A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition A: CPAP with No Humidification | Active Comparator | CPAP with No Humidification with no mouth leak |
|
| Condition B: CPAP with No Humidification | Active Comparator | CPAP with No Humidification with mouth leak |
|
| Condition C: CPAP with Cold Passover humidifier | Active Comparator | CPAP with Cold Passover humidifier with mouth leak |
|
| Condition D: CPAP with Modified Humidifier | Active Comparator | CPAP with Modified Humidifier with mouth leak |
|
| Condition E: CPAP with Ambient Tracking | Active Comparator | CPAP with Ambient Tracking with mouth leak |
|
| Condition F: CPAP with Heated Humidification |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Condition A: CPAP with No Humidification | Device | CPAP with No Humidification with no mouth leak |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Resistance | Will be measured by rhinomanometer or acoustic rhinometry | 8 Days |
| Evaluation of Nasal Dryness and Discomfort | Reported by participants using the Xero Questionnaire | 8 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Preference of Testing Condition | Measured by custom preference questionnaire | 8 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher and Paykel Healthcare | East Tamaki | Auckland | 2013 | New Zealand |
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CPAP with Heated Humidification at default setting with mouth leak |
|
| Condition G: CPAP with Heated Humidification | Active Comparator | CPAP with Heated Humidification at max setting with mouth leak |
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| Condition H: CPAP with New level humidification | Active Comparator | CPAP with New level humidification with mouth leak |
|
| Condition B: CPAP with No Humidification | Device | CPAP with No Humidification with mouth leak |
|
| Condition C: CPAP with Cold Passover | Device | CPAP with Cold Passover with mouth leak |
|
| Condition D: CPAP with Modified humidifier | Device | CPAP with Modified humidifier with mouth leak |
|
| Condition E: CPAP with Ambient Tracking | Device | CPAP with Ambient Tracking with mouth leak |
|
| Condition F: CPAP with Heated Humidification | Device | CPAP with Heated Humidification at default setting with mouth leak |
|
| Condition G: CPAP with Heated Humidification | Device | CPAP with Heated Humidification at max setting with mouth leak |
|
| Condition H: CPAP with New level humidification | Device | CPAP with New level humidification with mouth leak |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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