HGNS on Cardiovascular Outcomes

Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans.
If left untreated, it results in decreased quality of life and increased risk of heart
problems. Only half of these people are able to use the main treatment (CPAP) which involves
wearing a mask and hose at night. A new, well-tolerated treatment - tongue stimulation - is a
device which opens the airway during sleep and can provide treatment for patients unable to
use the mask and hose treatment. The study will evaluate the effect of this new treatment on
blood pressure and heart-related measures to see if it lowers patients' risk of heart
problems.

Inclusion Criteria:

- Must be established with the principal investigator, Raj Dedhia, MD for clinical care

- English-speaking and able to give written informed consent

- 21 years of age or older

- Apnea-hypopnea index (AHI) > 15 with < 25% central events on recent sleep testing

- Without circumferential collapse at velopharynx on drug-induced sedated endoscopy.

- Not able to use PAP > 4 hours for 5 nights/week or unwilling to use PAP

- Must be able to use the device at the therapeutic setting (> 20 hours per week for > 1
month) prior to enrollment based on compliance data

- All patients will have a pre-operative sleep study (baseline), 2-month in-lab sleep
study (titration) and if applicable, a post-HGNS sleep study (efficacy) available for
review

Exclusion Criteria:

- Pregnant women

- Patients with older remotes (due to limited adherence monitoring capabilities)

- Patient with an Epworth Sleepiness Scale > 16 at their initial consult visit (due to
higher risk of adverse events during non-treatment periods)

- Actively using PAP for obstructive sleep apnea