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Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

This study is looking at how treating obstructive sleep apnea (OSA) with Hypoglossal Nerve Stimulation (HGNS) might affect your body's sugar (glucose) levels and other factors that predict heart health. HGNS is an alternative treatment for OSA. You might be able to join if you are 18 or older, are overweight or obese (BMI 25-40 kg/m2), and have been diagnosed with OSA but can't use a CPAP machine. The researchers will measure changes in your blood sugar (glycemic variability) and blood pressure before and three months after you receive HGNS. The current status of this study is unclear.

Study design
This is an observational study planning to enroll 30 participants. It will look at changes in health markers over time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after receiving the HGNS implant, acclimation, and tuning.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06317701

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Recruiting
Not specifiedAges 18+Observational
University of Chicago
~30 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Hypoglossal Nerve Stimulation (HGNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycemic variability
Measured over at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
+2 more outcomes measured

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

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

Who to contact

Phillip LoSavio, MD, MS
[email protected]
773-702-5189
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Glycemic variabilityat 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)24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op

    important mediators of cardiovascular outcomes

  • 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