keePAP Device for Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: keePAP

• Registration Number: NCT01809418
• Lead Sponsor: keepMED Ltd.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-03-10
• Study First Submitted QC: 2013-03-10
• Study First Posted: 2013-03-12
• Study Start: 2013-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
keePAP	keePAP	-

Primary Outcome Measures

Name	Time	Method
AHI/RDI and oxygen saturation during sleep	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.

Secondary Outcome Measures

Name	Time	Method
Patient comfort	one night	Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel