Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea on Sympathetic and Vascular Function
Recruiting
21 years - 99 years
All
Phase
N/A
60 participants needed
1 Location
Brief description of study
The hypoglossal nerve controls tongue movement. The Inspire® sleep implant works by stimulating this nerve. This process is called hypoglossal nerve stimulation, or “HGNS.” In this study, we are interested in seeing how HGNS affects blood pressure and heart-related measures and if it lowers the risk of heart problems in people with obstructive sleep apnea.
Detailed description of study
If you decide to participate, we will test your cardiovascular function (described below) after a period of regular (“active”) Inspire treatment and after a period of very low (“sham therapy”) Inspire treatment. You will be blinded during both “sham” and “active” periods, which means that you will not be told which level of treatment you are having.
There will be 5 visits in total, which will take place on Days 1, 8, 36, 43, and 71.
We will also look in your medical record to collect information such as your age, sex, race, height, weight, whether you have been diagnosed with high blood pressure or diabetes, and the results of your routine care sleep tests, clinical follow-up visits, and other lab tests.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Sleep Apnea,Obstructive Sleep Apnea,OSA,Hypoglossal Nerve Stimulation,HGNS,Inspire
-
Age: 21 years - 99 years
-
Gender: All
Eligibility
Criteria:
Similar to criteria put forth by the Federal Drug
Administration (FDA), HGNS implantation inclusion criteria include:
·
Apnea-hypopnea index (AHI) greater than
15 with < 25% central events on recent sleep testing
·
Not able to use PAP > 4 hours for 5
nights/week or unwilling to use PAP
·
No circumferential collapse at
velopharynx on drug-induced sedated endoscopy
·
21 years of age or older.
·
As tolerating the therapeutic level
during sleep can take time (weeks to months), all patients 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. The patients
will be English-speaking and able to give written informed consent.
Exclusion Criteria
·
Inspire® remote model 2500
or later is required. Patients with older remotes are not candidates due to limited
adherence monitoring capabilities.
·
Patients who have fallen asleep while
driving resulting in accident or “near miss” accident within 1 year prior to
HGNS implantation.
·
Pregnant women will be excluded*
·
Actively using positive airway pressure
(PAP) therapy for treatment of OSA.
·
Patients in whom the difference between
sham and therapeutic voltages is less than 0.5 V.
*
Women of child bearing potential must NOT be pregnant or
plan on becoming pregnant. This study involves temporarily stopping treatment
of obstructive sleep apnea, which may harm the fetus. If applicable, the
patient will need to take a urine pregnancy test after enrollment (prior to
washout #1), and again prior to washout #2.
Updated on
19 Feb 2024.
Study ID: 834158
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