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Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Recruiting
Conditions
Obstructive Sleep Apnea
Interventions
Device: Hypoglossal Nerve Stimulation (HGNS)
Registration Number
NCT06317701
Lead Sponsor
University of Chicago
Brief Summary

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.

Detailed Description

Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder in the general population. It is estimated that 80 percent of those who have OSA remain undiagnosed, and thus do not receive therapy. Strong evidence from epidemiologic and clinical studies suggests that untreated OSA is an independent risk factor for cardiometabolic disease, particularly among those with moderate-to-severe OSA. Animal and human models have revealed that intermittent hypoxia and sleep fragmentation (i.e., main features of OSA) result in insulin resistance, glucose intolerance and pancreatic beta-cell dysfunction, hypertension and dyslipidemia. Continuous positive airway pressure (CPAP) is the established first-line treatment for OSA. However, only 50% of patients with OSA are adherent to CPAP therapy. Notably, a key limitation of prior CPAP trials on cardiometabolic outcomes is low treatment adherence.

A randomized controlled trial conducted at the University of Chicago demonstrated that 8 hours of nightly CPAP reduces glucose response during oral glucose tolerance testing and improves insulin sensitivity in individuals with OSA and prediabetes. In 2014, following the pivotal Safe and Timely Antithrombotic Removal - Ticagrelor trial (STAR), the Food and Drug Administration (FDA) approved hypoglossal nerve stimulation (HNS) as an alternative therapy for OSA. Five-year outcomes from STAR have confirmed durable efficacy, tolerance, and safety for HNS. From improved tolerance and adherence, it is theorized that HNS may be more effective than CPAP at ameliorating cardiovascular and diabetes risk. Yet, there is no literature on the cardiometabolic outcomes of treating OSA with HNS.

The study team's long-term goal is to understand the metabolic and cardiovascular effects of OSA and how current therapies can mitigate risk and improve outcomes. The overall objective of this study is to determine the cardiometabolic impact of HNS therapy in patients with moderate-to-severe OSA who are intolerant to CPAP. It is hypothesized by the investigator that effective HNS treatment will improve glucose metabolism and markers of cardiovascular disease.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
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
  • Absent circumferential collapse on Drug-Induced Sleep Endoscopy (DISE)
  • Not able to use positive airway pressure >4 hours for 5 nights/week or unwilling to use positive airway pressure
  • Weight stable (no change >25 lbs in the past 3 months)
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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)
  • Enrolled in a formal weight loss program or following an incompatible dietary regimen
  • Current systemic steroid use
  • Taking prescription medication or herbal remedy for weight loss
  • 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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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
HGNS Therapy ParticipantsHypoglossal Nerve Stimulation (HGNS)Individuals with sleep apnea treated by HGNS therapy.
Primary Outcome Measures
NameTimeMethod
Glycemic variabilityat 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

Mean systolic BP (daytime and nocturnal)24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op

important mediators of cardiovascular outcomes

Secondary Outcome Measures
NameTimeMethod
time blocks24-h, day, night at baseline and after HGNS implant, acclimation, and tuning

glycemic metrics for the clinical care of diabetes will be followed

Morning fasting insulin, including calculated insulin resistance (HOMA-IR)at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
heart rate indices by activity monitorat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

testing for signs of cardiovascular disease

Morning fasting insulin of c-peptide levelat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Mean norepinephrine levelsat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
mean blood glucose levelsat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

other glycemic metrics for the clinical care of diabetes to be followed.

Morning fasting blood glucoseat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

markers of glucose metabolism

fasting lipid profile (triglycerides)at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

testing for signs of cardiovascular disease

Hemoglobin A1cat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

markers of glucose metabolism

Insulin levelsat baseline and after HGNS implant, acclimation, and tuning

markers of glucose metabolism

fasting lipid profile (HDL- cholesterol)at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

testing for signs of cardiovascular disease

fasting lipid profile ( LDL-cholesterol)at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

testing for signs of cardiovascular disease

mean ambulatory glucose excursionsat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

glycemic metrics for the clinical care of diabetes will be followed

c-peptide levelsat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

markers of glucose metabolism

sympathetic activity by plasma norepinephrineat baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op

to investigate its role as a mediator in cardiometabolic response to treatment

Trial Locations

Locations (1)

The University of Chicago

🇺🇸

Chicago, Illinois, United States

The University of Chicago
🇺🇸Chicago, Illinois, United States
Phillip LoSavio, MD, MS
Principal Investigator
Leila Yazdanbakhsh
Contact
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