Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

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.

Conditions

Obstructive Sleep Apnea

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Chicago

The University of Chicago, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Chicago,

Phillip LoSavio, MD, MS, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2028-04