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Blood sugar changes in sleep apnea after tongue nerve stimulation

Looks at glucose handling and heart risk markers after nerve stimulation for obstructive sleep apnea.

Key facts

Who runs it
University of Chicago
Where
Chicago, United StatesSee the site
Trial code
Registry title
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Status
Recruiting
People taking part
30 people, planned
Started
4 Apr 2024
Expected to end
Apr 2028
Type of study
Observational, 2 groups
Treatments tested
  • Hypoglossal Nerve Stimulation (HGNS)
Record updated
28 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for overweight or obese adults with obstructive sleep apnea who cannot or will not use positive airway pressure (PAP). It studies whether hypoglossal nerve stimulation (HGNS) changes blood sugar handling and heart risk markers.

Age
18 years and older
Sex
Male and female
Disease stage
Obstructive sleep apnea with an Apnea-Hypopnea Index >15 events/hr (4% oxygen drop criteria) and < 25% central events/hr on a prior home or in-lab sleep test. BMI 25 kg/m2 to 40 kg/m2.
Earlier treatment
People must be unable to use positive airway pressure >4 hours for 5 nights/week, or unwilling to use it. Regular CPAP users cannot join.

Main reasons for not taking part

  • Diabetes that needs insulin
  • Brain or nerve disease with memory problems or muscle weakness, such as stroke
  • Pregnant, trying to get pregnant or breastfeeding
  • Night shift or rotating shift work, or another sleep disorder
  • Current steroid pills or injections, or mainly central sleep apnea, or needing oxygen or bi-level PAP

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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 cannot take part

  • Current systemic steroid use
  • Insulin-dependent Diabetes
  • Central Nervous System (CNS) disease with impairment of cognitive function (dementia) and/or muscle paresis, such as stroke
  • Diagnosis of another sleep disorder (e.g. periodic limb movement disorder)
  • age < 18 years
  • Inability to undergo in-lab polysomnography or home sleep testing
  • Currently pregnant, trying to get pregnant or nursing
  • Regular and adherent CPAP use per clinical guidelines
  • Current night shift or rotating shift work
  • 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 in United States

  • The University Of ChicagoChicago, United StatesContact: Phillip LoSavio, MD, MSTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • HGNS Therapy Participants

    Individuals with sleep apnea treated by HGNS therapy.

    Treatment: Hypoglossal Nerve Stimulation (HGNS)

  • patients with OSA and complete concentric airway collapse on DISE

    By standard of care, patients undergoing evaluation for HGNS as an alternative therapy for OSA must undergo drug-induced sleep endoscopy (DISE) to confirm anterior-posterior airway collapse (APC) and rule out complete concentric airway collapse (CCC). Currently, no studies have described the cardiometabolic profiles of patients with OSA and CCC - a population that is both intolerant to PAP and ineligible for HGNS. participants with CCC on DISE will complete an identical set of measures as the APC group. Due to the presence of CCC, these participants will not undergo surgery and will only receive testing once. Data from these subjects will be compared against the baseline (pre-operative) data of the APC group.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Hgns: Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Plain-language title
Blood sugar changes in sleep apnea after tongue nerve stimulationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
28 January 2026