Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Recruiting
Observational Study
Obstructive Sleep Apnea
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for people with obstructive sleep apnea who are overweight or obese. Participants will receive a treatment called hypoglossal nerve stimulation to see if it can help with their condition and improve their overall health.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 40 years old.
I have obstructive sleep apnea diagnosed by a sleep test.
I am overweight or obese with a BMI between 25 and 40.
I am unable or unwilling to use a CPAP machine.
You may not be able to join if
I have insulin-dependent diabetes.
I am currently pregnant, trying to get pregnant, or nursing.
I have a serious brain or nerve condition that affects my thinking or movement.
I cannot undergo a sleep study.
I have another sleep disorder.
I use a CPAP machine regularly.
I have a current medical condition that requires steroid use.
I am under legal guardianship or can't make my own decisions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to determine if the treatment of Obstructive sleep apnea (OSA) by hypoglossal nerve stimulation (HGNS) will alter glucose metabolism. The study team will also determine if the treatment of Obstructive sleep apnea (OSA) by (hypoglossal nerve stimulation) HGNS will alter predictors of cardiovascular outcomes.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Overweight or obese males and females BMI 25 kg/m2 to 40 kg/m2
* Age 18 years and older
* Diagnosed with obstructive sleep apnea by Apnea-Hypopnea Index \>15 events/hr using 4% oxygen desaturation criteria and \< 25% central events/hr on prior sleep testing Data can be derived…
Inclusion Criteria:
* Overweight or obese males and females BMI 25 kg/m2 to 40 kg/m2
* Age 18 years and older
* Diagnosed with obstructive sleep apnea by Apnea-Hypopnea Index \>15 events/hr using 4% oxygen desaturation criteria and \< 25% central events/hr on prior sleep testing Data can be derived from home sleep testing or in-lab polysomnogram
* Not able to use positive airway pressure \>4 hours for 5 nights/week or unwilling to use positive airway pressure
Exclusion Criteria:
* Insulin-dependent Diabetes
* Inability to undergo in-lab polysomnography or home sleep testing
* Central Nervous System (CNS) disease with impairment of cognitive function (dementia) and/or muscle paresis, such as stroke
* Currently pregnant, trying to get pregnant or nursing
* age \< 18 years
* Regular and adherent CPAP use per clinical guidelines
* Current night shift or rotating shift work
* Diagnosis of another sleep disorder (e.g. periodic limb movement disorder)
* Current systemic steroid use
* Predominantly central sleep apnea or requiring oxygen or bi-level positive airway pressure or advanced positive airway pressure modalities
* Protected patient: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, including hospitalized without consent
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