Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BONGO DEVICE
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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)
Sites / Locations
- California Center for Sleep Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BONGO DEVICE
Arm Description
All participants that qualify will receive the intervention of the Bongo device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02878590
First Posted
August 22, 2016
Last Updated
January 31, 2019
Sponsor
InnoMed Healthscience Inc.
Collaborators
RVW Clinical Consulting
1. Study Identification
Unique Protocol Identification Number
NCT02878590
Brief Title
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Official Title
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoMed Healthscience Inc.
Collaborators
RVW Clinical Consulting
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BONGO DEVICE
Arm Type
Experimental
Arm Description
All participants that qualify will receive the intervention of the Bongo device
Intervention Type
Device
Intervention Name(s)
BONGO DEVICE
Intervention Description
A device to be used for the treatment of mild to moderate obstructive sleep apnea
Primary Outcome Measure Information:
Title
Change in Apnea-Hypopnea Index (AHI)
Description
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.
Time Frame
At Diagnostic Baseline PSG and at Final Treatment PSG with the device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jerrold kram, MD
Organizational Affiliation
California Center for Sleep Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Center for Sleep Disorders
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
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