Completed

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

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What is being tested

keePAP

Device
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorkeepMED Ltd.
Last updated: April 3, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01809418
Principal SponsorkeepMED Ltd.
Last updated: April 3, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea, Obstructive

Criteria

2 inclusion criteria required to participate
AHI/RDI > 5
Age over between 18 and 80 years old
8 exclusion criteria prevent from participating
Any nasal, facial or head abnormalities that would not allow adequate placement of the device
Any previous operation or trauma to the nose
Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment
Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Soroka Medical Center

Beersheba, IsraelOpen Soroka Medical Center in Google Maps
CompletedOne Study Center