Obstructive Sleep Apnea
Conditions
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.
Interventions
DEVICEBONGO DEVICE
A device to be used for the treatment of mild to moderate obstructive sleep apnea
Sponsors
RVW Clinical Consulting
InnoMed Healthscience Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | At Home Bongo Users |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 12.8 |
| Body Mass Index (BMI) | 31.6 kg/m^2 STANDARD_DEVIATION 5.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Population: All subjects that completed the entire study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| At Home Bongo Users | Change in Apnea-Hypopnea Index (AHI) | Baseline AHI with no device | 15.7 events per hour | Standard Deviation 6.4 |
| At Home Bongo Users | Change in Apnea-Hypopnea Index (AHI) | AHI with Bongo R1 device | 7.1 events per hour | Standard Deviation 4.2 |
| At Home Bongo Users | Change in Apnea-Hypopnea Index (AHI) | Change in AHI | -8.7 events per hour | Standard Deviation 8.3 |
p-value: 0.0093t-test, 2 sided