Obstructive Sleep Apnea Clinical Trial
Official title:
Clinical Study for the BONGO NASAL EPAP Device in the Treatment of Obstructive Sleep Apnea (OSA)
Verified date | August 2017 |
Source | InnoMed Healthscience Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 9 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Sleep Therapy and Research Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
InnoMed Healthscience Inc. | RVW Clinical Consulting |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apnea Hypopnea Index | 2 weeks |
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