An interventional study of BONGO DEVICE in Obstructive Sleep Apnea, sponsored by InnoMed Healthscience Inc.. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by InnoMed Healthscience Inc. · Not applicable, Interventional, and Treatment
Prospective, non-randomized, open label study
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 23 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →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.
Capacity and willingness to sign informed consent
Exclusion Criteria:
Nasal deformities
All participants that qualify will receive the intervention of the Bongo device
Device: BONGO DEVICE
A device to be used for the treatment of mild to moderate obstructive sleep apnea
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.
Time frame: At Diagnostic Baseline PSG and at Final Treatment PSG with the device
| Milestone | At Home Bongo Users |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| events per hour | At Home Bongo Users |
|---|---|
| Baseline AHI with no device | 15.7 ± 6.4 |
| AHI with Bongo R1 device | 7.1 ± 4.2 |
| Change in AHI | -8.7 ± 8.3 |
Collected over On each subject from their screening visit to their final study termination visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BONGO DEVICE | 0/23 (0%) | 0/23 (0%) | 2/23 (8.7%) |
| Event | BONGO DEVICE |
|---|---|
| Chest discomfortRespiratory, thoracic and mediastinal disorders | 1/23 |
| Nasal abrasionSkin and subcutaneous tissue disorders | 1/23 |
All subjects that completed the entire study.
| Age, Continuous(years) | At Home Bongo Users |
|---|---|
| Mean | 52.7 ± 12.8 |
| Sex: Female, Male(Participants) | At Home Bongo Users |
|---|---|
| Female | 4 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | At Home Bongo Users |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 2 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Body Mass Index (BMI)(kg/m^2) | At Home Bongo Users |
|---|---|
| Mean | 31.6 ± 5.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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InnoMed Healthscience Inc.