keePAP Device for Treatment of Obstructive Sleep Apnea

April 2, 2018 updated by: keepMED Ltd.

Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: keePAP
Device: keePAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comfort
Time Frame: one night
Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.
one night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

keepMED Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 10, 2013

First Submitted That Met QC Criteria

March 10, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • keePAP-1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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