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Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)

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: NCT02590159
Recruitment Status : Terminated (delay in enrollment)
First Posted : October 28, 2015
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
RVW Clinical Consulting
Information provided by (Responsible Party):
InnoMed Healthscience Inc.

Brief Summary:
Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: BONGO NASAL EPAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study for the BONGO NASAL EPAP Device in the Treatment of Obstructive Sleep Apnea (OSA)
Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea


Intervention Details:
  • Device: BONGO NASAL EPAP
    The BONGO NASAL EPAP device consists of two nasal inserts (a connected pair), each containing an actuated valve, with a patient attachment mechanism. The device works by providing an inhalation port that offers minimal inhale resistance during inhalation, but is closed by the actuated valve so that exhalation occurs against a fixed orifice. This mechanism provides increased EPAP upon exhalation.


Primary Outcome Measures :
  1. Apnea Hypopnea Index [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capacity and willingness to sign informed consent
  • ≥ 21 years of age
  • Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI < 30) within 12 months of the screening visit.
  • Able to tolerate using the device during a day time trial/acclimation
  • Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

Exclusion Criteria:

  • Nasal deformities
  • Severe nasal allergies
  • Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
  • Co-morbid sleep disorders
  • Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
  • Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
  • Full Face Mask user
  • Mouth breather
  • Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)

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): NCT02590159


Locations
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United States, Texas
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
InnoMed Healthscience Inc.
RVW Clinical Consulting
Investigators
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Principal Investigator: Nagwa Lamaie, MD Sleep Therapy and Research Center
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Responsible Party: InnoMed Healthscience Inc.
ClinicalTrials.gov Identifier: NCT02590159    
Other Study ID Numbers: INN-C002
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases