Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: FPH Device with SensAwake On + Pressure Support A
* Device: FPH Device with SensAwake Off + Pressure Support A
* Device: FPH Device with SensAwake On + Pressure Support B
* Device: FPH Device with SensAwake Off + Pressure Support B
* Device: Competitor's PAP Released Device + Pressure Support A
* Device: Competitor's PAP Released Device + Pressure Support B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and over Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP. For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator) Exclusion Criteria: Contraindicated for PAP (CPAP or AutoCPAP) therapy Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea) Persons with obesity hypoventilation syndrome or congestive heart failure. Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device Persons with implanted electronic medical device (e.g cardiac pacemakers) Persons who are pregnant or think they might be pregnant.

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FPH Device with SensAwake On + Pressure Support A<br>FPH Device with SensAwake On + Pressure Support A | Device: FPH Device with SensAwake On + Pressure Support A<br>* FPH Device with SensAwake On + Pressure Support A<br>|
| Active Comparator: FPH Device with SensAwake Off + Pressure Support A<br>FPH Device with SensAwake Off + Pressure Support A | Device: FPH Device with SensAwake Off + Pressure Support A<br>* FPH Device with SensAwake Off + Pressure Support A<br>|
| Active Comparator: FPH Device with SensAwake On + Pressure Support B<br>FPH Device with SensAwake On + Pressure Support B | Device: FPH Device with SensAwake On + Pressure Support B<br>* FPH Device with SensAwake On + Pressure Support B<br>|
| Active Comparator: FPH Device with SensAwake Off + Pressure Support B<br>FPH Device with SensAwake Off + Pressure Support B | Device: FPH Device with SensAwake Off + Pressure Support B<br>* FPH Device with SensAwake Off + Pressure Support B<br>|
| Active Comparator: Competitor's PAP Released Device + Pressure Support A<br>Competitor's PAP Released Device + Pressure Support A | Device: Competitor's PAP Released Device + Pressure Support A<br>* Competitor's PAP Released Device + Pressure Support A<br>|
| Active Comparator: Competitor's PAP Released Device + Pressure Support B<br>Competitor's PAP Released Device + Pressure Support B | Device: Competitor's PAP Released Device + Pressure Support B<br>* Competitor's PAP Released Device + Pressure Support B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) | Through the device and independent flow logger | 3 nights | 
| Apnea Hypopnea Index (AHI) | Through the polysomnography | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Comfort | Through a subjective questionnaire | 3 nights | 
| Compliance | Through the device and independent flow logger | 3 nights | 
| Device Triggering | Through the device | 3 nights | 
| Device Triggering | Through the polysomnography | 1 night |