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

NCT04875897 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-09-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

keepMED PAP device

The keepMED PAP device is an automatic, wearable positive airway pressure device indicated for treatment of obstructive sleep apnea. A therapeutic pressure is delivered to the patient upper airway through a nasal interface. It is similar to other marketed positive airway pressure devices with respect to its fundamental use of positive airway pressure for the treatment of sleep apnea as well as with regard to its functional components and accessories (e.g., a PAP unit, a mask/nasal interface, an air filter, tubing, etc.).

Sponsors & Collaborators

  • CRI-The Clinical Research Institute GmbH

    collaborator INDUSTRY

  • keepMED Ltd.

    lead INDUSTRY

Principal Investigators

  • Jean-Louis Pépin, Prof · CHU Michallon Laboratoire EFCR CS 10217

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2022-01-15
Completion
2022-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875897 on ClinicalTrials.gov