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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878590
• Other study ID #: INN-C003
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2019
• Source: InnoMed Healthscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, non-randomized, open label study

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• 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 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)

Related Conditions & MeSH terms

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

Intervention

Device:
• BONGO DEVICE
A device to be used for the treatment of mild to moderate obstructive sleep apnea

Locations

Country	Name	City	State
United States	California Center for Sleep Disorders	Alameda	California

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	Change in Apnea-Hypopnea Index (AHI)	Obstructive Sleep Apnea (OSA) severity is divided into three categories based on the Apnea-Hypopnea Index (AHI) as follows: Mild (AHI of 5 to 15), Moderate (AHI of 15 to 30), and Severe (AHI > 30). AHI is calculated by dividing the number of events (i.e. Apneas and hypopneas) by the number of hours of sleep. The primary outcome for the study was change in AHI, defined as the difference in AHI between the diagnostic PSG study (baseline with no device) and the final PSG study with the Bongo device for the subjects that completed the entire study.	At Diagnostic Baseline PSG and at Final Treatment PSG with the device