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keePAP Device for Treatment of Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809418
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ninox Medical 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: keePAP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of the keePAP Device in Reducing the Number of Obstructive Breathing Events
Study Start Date : July 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: keePAP Device: keePAP



Primary Outcome Measures :
  1. AHI/RDI and oxygen saturation during sleep [ Time Frame: 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 :
  1. Patient comfort [ Time Frame: one night ]
    Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809418


Locations
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Israel
Soroka Medical Center
Beer Sheva, Israel
Sponsors and Collaborators
Ninox Medical Ltd
Investigators
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Principal Investigator: Asher Tal, MD Soroka University Medical Center

Publications:
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Responsible Party: Ninox Medical Ltd
ClinicalTrials.gov Identifier: NCT01809418     History of Changes
Other Study ID Numbers: keePAP-1.0
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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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

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases