Obstructive Sleep Apnea
Conditions
Brief summary
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
Interventions
DEVICEBONGO NASAL EPAP
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.
Sponsors
RVW Clinical Consulting
InnoMed Healthscience Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index | 2 weeks |
Countries
United States
Outcome results
None listed