Status:
COMPLETED
keePAP Device for Treatment of Obstructive Sleep Apnea
Lead Sponsor:
keepMED Ltd.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
Phase:
NA
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 Res...
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 n...
Eligibility Criteria
Inclusion
- Age over between 18 and 80 years old;
- AHI/RDI \> 5
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01809418
Start Date
July 1 2013
End Date
October 1 2017
Last Update
April 3 2018
Active Locations (1)
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1
Soroka Medical Center
Beersheba, Israel