Trial Outcomes & Findings for Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA) (NCT NCT02878590)
NCT ID: NCT02878590
Last Updated: 2019-02-19
Results Overview
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.
COMPLETED
NA
23 participants
At Diagnostic Baseline PSG and at Final Treatment PSG with the device
2019-02-19
Participant Flow
23 subjects were enrolled (i.e. given a subject number). 6 subjects did not meet the inclusion / exclusion criteria. 5 subjects did not qualify to use the Bongo device at home.
Participant milestones
| Measure |
At Home Bongo Users
Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
At Home Bongo Users
Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Baseline characteristics by cohort
| Measure |
At Home Bongo Users
n=10 Participants
Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: At Diagnostic Baseline PSG and at Final Treatment PSG with the devicePopulation: All subjects that completed the entire study.
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.
Outcome measures
| Measure |
At Home Bongo Users
n=10 Participants
Subjects that qualified to use the Bongo at home for a two week period followed by a in-laboratory, overnight polysomnogram (PSG).
|
|---|---|
|
Change in Apnea-Hypopnea Index (AHI)
Baseline AHI with no device
|
15.7 events per hour
Standard Deviation 6.4
|
|
Change in Apnea-Hypopnea Index (AHI)
AHI with Bongo R1 device
|
7.1 events per hour
Standard Deviation 4.2
|
|
Change in Apnea-Hypopnea Index (AHI)
Change in AHI
|
-8.7 events per hour
Standard Deviation 8.3
|
Adverse Events
BONGO DEVICE
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BONGO DEVICE
n=23 participants at risk
All participants that qualify will receive the intervention of the Bongo device
BONGO DEVICE: A device to be used for the treatment of mild to moderate obstructive sleep apnea
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
4.3%
1/23 • On each subject from their screening visit to their final study termination visit.
|
|
Skin and subcutaneous tissue disorders
Nasal abrasion
|
4.3%
1/23 • On each subject from their screening visit to their final study termination visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place