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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
A device to be used for the treatment of mild to moderate obstructive sleep apnea
California Center for Sleep Disorders
Alameda, California, United States
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
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