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Locations near you
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Full eligibility criteria for NCT02878590
Ages eligible for Study
21 Years and older
Genders 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 with the 3% hypopnea criteria
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)
• 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
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)
All locations for NCT02878590
United States (1)
CONCERT Study Site
Alameda, California, United States, 94501
Trial results for NCT02878590
Participant Flow: Overall Study
At Home Bongo Users
10 / 12
Completed / Started
Serious Adverse Events
0 / 46
Affected / At Risk
Other Adverse Events
2 / 23
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT02878590. The sponsor of the trial is InnoMed Healthscience Inc. and it is looking for 23 volunteers for the current phase.
Official trial title: Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea
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