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

NCT ID: NCT02878590

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-11-30

Brief Summary

Prospective, non-randomized, open label study

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BONGO DEVICE

All participants that qualify will receive the intervention of the Bongo device

Group Type: EXPERIMENTAL

BONGO DEVICE

Intervention Type: DEVICE

A device to be used for the treatment of mild to moderate obstructive sleep apnea

Interventions

BONGO DEVICE

A device to be used for the treatment of mild to moderate obstructive sleep apnea

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RVW Clinical Consulting

INDUSTRY

Sponsor Role: collaborator

InnoMed Healthscience Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jerrold kram, MD

Role: PRINCIPAL_INVESTIGATOR

California Center for Sleep Disorders

Locations

California Center for Sleep Disorders

Alameda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INN-C003

Identifier Type: -

Identifier Source: org_study_id