keePAP Device for Treatment of Obstructive Sleep Apnea

keepMED

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: keePAP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01809418

keePAP-1.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment

11 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.