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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: BONGO DEVICE

• Registration Number: NCT02878590
• Lead Sponsor: InnoMed Healthscience Inc.

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Study Start: 2016-09
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Results First Submitted: 2018-11-30
• Results First Submitted QC: 2018-11-30
• Results First Posted: 2018-12-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BONGO DEVICE	BONGO DEVICE	All participants that qualify will receive the intervention of the Bongo device

Primary Outcome Measures

Name	Time	Method
Change in Apnea-Hypopnea Index (AHI)	At Diagnostic Baseline PSG and at Final Treatment PSG with the device	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.

Trial Locations

Locations (1)

California Center for Sleep Disorders; 🇺🇸 Alameda, California, United States