keePAP Device for Treatment of Obstructive Sleep Apnea

keepMED Ltd.11 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

keePAPDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Soroka Medical Center

Beersheba, Israel

Outcomes

Primary Outcomes

AHI/RDI and oxygen saturation during sleep

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.

Time frame: one night

Secondary Outcomes

Patient comfort

Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.

Time frame: one night

Data from ClinicalTrials.gov

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