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TerminatedNCT02590159Updated Aug 21, 2017

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

An interventional study of BONGO NASAL EPAP in Obstructive Sleep Apnea, sponsored by InnoMed Healthscience Inc.. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-08-21.

Sponsored by InnoMed Healthscience Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
delay in enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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

02

Conditions studied

03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 9 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

InnoMed Healthscience Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Interventions

  • DeviceBONGO 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.

06

What researchers measure

Primary outcomes

  1. Apnea Hypopnea Index

    Time frame: 2 weeks

07

Study locations

1 site
  • Sleep Therapy and Research Center
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02590159
Lead sponsor
InnoMed Healthscience Inc.
Collaborators
RVW Clinical Consulting
Responsible party
Sponsor
First posted
Oct 28, 2015
Start date
Nov 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 21, 2017

Study contacts

Nagwa Lamaie, MD
principal investigator · Sleep Therapy and Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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