keePAP Device for Treatment of Obstructive Sleep Apnea
|ClinicalTrials.gov Identifier: NCT01809418|
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: keePAP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
- AHI/RDI and oxygen saturation during sleep [ Time Frame: 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.
- Patient comfort [ Time Frame: one night ]Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809418
|Soroka Medical Center|
|Beer Sheva, Israel|
|Principal Investigator:||Asher Tal, MD||Soroka University Medical Center|