Recruiting

Cranial Nerve Stimulation

Sponsor:

University of Chicago

Code:

NCT06317701

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hypoglossal Nerve Stimulation (HGNS)

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06317701

Start date

Apr 4, 2024

Status verified date

Jan, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

HGNS Therapy Participants

Individuals with sleep apnea treated by HGNS therapy.

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.

Interventions

Hypoglossal Nerve Stimulation (HGNS)

Alternative therapy for Obstructive Sleep Apnea

Primary outcome measure

  • Glycemic variability [ Time Frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op ]
  • Mean systolic BP (daytime and nocturnal) [ Time Frame: 24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op ]
  • Glycemic variability [ Time Frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op ]

Central Contacts and Locations

Central contacts

Phillip LoSavio, MD, MS

773-702-5189Phillip.Losavio@bsd.uchicago.edu

Carlisa Dixon

773-834-4337cdixon520@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Phillip LoSavio, MD, MS

773-702-5189Phillip.Losavio@bsd.uchicago.edu

Leila Yazdanbakhsh

773-834-5087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Phillip LoSavio, MD, MS

More Information

Sponsor

University of Chicago

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-01-28.