Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)
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ClinicalTrials.gov Identifier: NCT02590159
Recruitment Status :
(delay in enrollment)
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.
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Layout table for eligibility information
Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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
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)