Back to resultskeePAP Device for Treatment of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
keePAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- Soroka Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
keePAP
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient comfort
Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01809418
Brief Title
keePAP Device for Treatment of Obstructive Sleep Apnea
Official Title
Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
keepMED Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
keePAP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
keePAP
Primary Outcome Measure Information:
Title
AHI/RDI and oxygen saturation during sleep
Description
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 Outcome Measure Information:
Title
Patient comfort
Description
Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.
Time Frame
one night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Tal, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer Sheva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
10450601
Citation
Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
Results Reference
background
Learn more about this trial
keePAP Device for Treatment of Obstructive Sleep Apnea
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