keePAP Device for Treatment of Obstructive Sleep Apnea
Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedApril 3, 2018
April 1, 2018
4.3 years
March 10, 2013
April 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
one night
Secondary Outcomes (1)
Patient comfort
one night
Study Arms (1)
keePAP
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age over between 18 and 80 years old;
- AHI/RDI \> 5
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- keepMED Ltd.lead
Study Sites (1)
Soroka Medical Center
Beersheba, Israel
Related Publications (1)
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.
PMID: 10450601BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asher Tal, MD
Soroka University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2013
First Posted
March 12, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
April 3, 2018
Record last verified: 2018-04