CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
BONGO DEVICEdevice
Likely dose
BONGO Device for mild to moderate obstructive sleep apneaAI-extracted
Key inclusion· 4
  • ✓Age ≥21 years
  • ✓Diagnosis of mild to moderate OSA with AHI ≥5 and ≤30 (using 3% hypopnea criteria) diagnosed within 12 months of screening
  • ✓Currently using CPAP or prescribed CPAP but non-adherent or unwilling to use
  • ✓Able to tolerate device during daytime trial/acclimation
Key exclusion· 9
  • ✕Nasal deformities
  • ✕Severe nasal allergies
  • ✕Rhinitis, moderate nasal congestion, or acute upper respiratory inflammation/infection; perforation of eardrum
  • ✕Co-morbid sleep disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02878590
NCT02878590N/ACompleted
CompareCT.gov

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

InnoMed Healthscience Inc.·interventional·Posted Aug 25, 2016·Updated Feb 19, 2019

In Brief

A clinical study evaluating BONGO DEVICE for Obstructive Sleep Apnea. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Prospective, non-randomized, open label study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
CollaboratorsRVW Clinical Consulting

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartSep 1, 2016
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.9 years ago

Interventions

BONGO DEVICEdevice

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