Humidification Needs

Study Overview
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Brief Summary
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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.

Official Title
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Humidification Needs

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Condition A: CPAP with No Humidification
* Device: Condition B: CPAP with No Humidification
* Device: Condition C: CPAP with Cold Passover
* Device: Condition D: CPAP with Modified humidifier
* Device: Condition E: CPAP with Ambient Tracking
* Device: Condition F: CPAP with Heated Humidification
* Device: Condition G: CPAP with Heated Humidification
* Device: Condition H: CPAP with New level humidification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and over Exclusion Criteria: Inability to give consent Currently pregnant or think they may be pregnant Current nasal symptoms or chronic nasal disease Contraindicated for PAP therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Condition A: CPAP with No Humidification<br>CPAP with No Humidification with no mouth leak | Device: Condition A: CPAP with No Humidification<br>* CPAP with No Humidification with no mouth leak<br>|
| Active Comparator: Condition B: CPAP with No Humidification<br>CPAP with No Humidification with mouth leak | Device: Condition B: CPAP with No Humidification<br>* CPAP with No Humidification with mouth leak<br>|
| Active Comparator: Condition C: CPAP with Cold Passover humidifier<br>CPAP with Cold Passover humidifier with mouth leak | Device: Condition C: CPAP with Cold Passover<br>* CPAP with Cold Passover with mouth leak<br>|
| Active Comparator: Condition D: CPAP with Modified Humidifier<br>CPAP with Modified Humidifier with mouth leak | Device: Condition D: CPAP with Modified humidifier<br>* CPAP with Modified humidifier with mouth leak<br>|
| Active Comparator: Condition E: CPAP with Ambient Tracking<br>CPAP with Ambient Tracking with mouth leak | Device: Condition E: CPAP with Ambient Tracking<br>* CPAP with Ambient Tracking with mouth leak<br>|
| Active Comparator: Condition F: CPAP with Heated Humidification<br>CPAP with Heated Humidification at default setting with mouth leak | Device: Condition F: CPAP with Heated Humidification<br>* CPAP with Heated Humidification at default setting with mouth leak<br>|
| Active Comparator: Condition G: CPAP with Heated Humidification<br>CPAP with Heated Humidification at max setting with mouth leak | Device: Condition G: CPAP with Heated Humidification<br>* CPAP with Heated Humidification at max setting with mouth leak<br>|
| Active Comparator: Condition H: CPAP with New level humidification<br>CPAP with New level humidification with mouth leak | Device: Condition H: CPAP with New level humidification<br>* CPAP with New level humidification with mouth leak<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of Testing Condition | Measured by custom preference questionnaire | 8 Days |