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Keep this study
Lead
InnoMed Healthscience Inc.
With
RVW Clinical Consulting
This study is a prospective, non-randomized, open label, single-center clinical study for the BONGO NASAL device for the treatment of obstructive sleep apnea. The study consists of two in laboratory polysomnographic studies and a one two week in home period.
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
• 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)
You may not be if
• 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)
