Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT02590159
• Lead Sponsor: InnoMed Healthscience Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	2 weeks

Trial Locations

Locations (1)

Sleep Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States