NCT06317701 · University of Chicago
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Hypoglossal Nerve Stimulation (HGNS)
Alternative therapy for Obstructive Sleep Apnea
Primary outcome measures
Glycemic variability
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
measured by standard deviation (SD) of average blood glucose or % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
Mean systolic BP (daytime and nocturnal)
Time frame: 24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
important mediators of cardiovascular outcomes
Glycemic variability
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
measured by standard deviation (SD) of % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 28, 2026 · Source of record for eligibility and locations