keePAP Device for Treatment of Obstructive Sleep Apnea

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

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.

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.

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.