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Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea — keePaOSA  

Obstructive Sleep Apnea Clinical Trial

Official title:
KeepMED-away-Obstructive Sleep Apnea Trial: Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea - keePaOSA

Clinical Trial Summary

A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device. The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab. Secondarily, the safety of the use of the device in this setting is assessed.

Clinical Trial Description

The study includes a baseline visit, a habituation night, and a therapy night. Both nights will be undertaken in the sleep lab under identical conditions and will include the keepMED PAP therapy activated in parallel to polysomnography (PSG). Baseline diagnostic PSG, performed within one month prior to enrollment to the study, will be used to assess the device efficacy. An interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. The sample size will be re-estimated based on the observed changes of AHI in the interim analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04875897
Study type Interventional
Source keepMED Ltd.
Contact Pierre-Charles Neuzeret, PhD
Phone +49 152 554 22500
Email pierre-charles@keepmed.com
Status Not yet recruiting
Phase N/A
Start date September 14, 2021
Completion date February 28, 2022
View Details
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