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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02590159
• Other study ID #: INN-C002
• Status: Terminated
• Phase: N/A
• First received: October 27, 2015
• Last updated: August 16, 2017
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: InnoMed Healthscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• BONGO 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.

Locations

Country	Name	City	State
United States	Sleep Therapy and Research Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
InnoMed Healthscience Inc.	RVW Clinical Consulting

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index		2 weeks