Expired Study
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San Antonio, Texas 78229


Purpose:

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


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)


NCT ID:

NCT02590159


Primary Contact:

Principal Investigator
Nagwa Lamaie, MD
Sleep Therapy and Research Center


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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