keePAP Device for Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.

Detailed Description
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Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems. The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.

Official Title
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Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: keePAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over between 18 and 80 years old; AHI/RDI > 5 Exclusion Criteria: Uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure), Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment; History of severe nasal allergies or sinusitis or difficulty breathing through the nose; Persistent blockage of one or both nostrils; Any previous operation or trauma to the nose; Any nasal, facial or head abnormalities that would not allow adequate placement of the device. Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure. Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: keePAP<br> | Device: keePAP<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI/RDI and oxygen saturation during sleep | Efficacy of the keePAP system in reducing the number of obstructive breathing events during sleep as indexed by the AHI and measures of oxygen saturation during sleep. | one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort | Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered. | one night |