Obstructive Sleep Apnea
Conditions
Brief summary
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
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.
Interventions
DEVICEkeePAP
Sponsors
keepMED Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AHI/RDI and oxygen saturation during sleep | one night | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort | one night | Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered. |
Countries
Israel
Outcome results
None listed