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RECRUITINGOBSERVATIONAL

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Hgns: Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Hypoglossal Nerve Stimulation (HGNS)

Alternative therapy for Obstructive Sleep Apnea

Locations (1)

The University of Chicago
Chicago, Illinois, United States