Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)

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.

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 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)

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)