Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

NCT06317701 | Recruiting FDA Device

• 1 other identifier: IRB23-1801
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Glycemic variability

  measured by standard deviation (SD) of average blood glucose or % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor

  at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op

• Mean systolic BP (daytime and nocturnal)

  important mediators of cardiovascular outcomes

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

• Glycemic variability

  measured by standard deviation (SD) of % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor

  at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op

Secondary Outcomes (15)

• mean blood glucose levels

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

• mean ambulatory glucose excursions

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

• time blocks

  24-h, day, night at baseline and after HGNS implant, acclimation, and tuning

• Morning fasting insulin, including calculated insulin resistance (HOMA-IR)

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

• Mean norepinephrine levels

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

Study Arms (2)

HGNS Therapy Participants

Individuals with sleep apnea treated by HGNS therapy.

Device: 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.

Interventions

Hypoglossal Nerve Stimulation (HGNS) DEVICE

Alternative therapy for Obstructive Sleep Apnea

HGNS Therapy Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be recruited from the Sleep Surgery Clinic of the Duchossois Center for Advanced Medicine (DCAM) in Hyde Park and Sleep Surgery Clinic of UChicago Medicine - Orland Park and Hinsdale.. We will take advantage of the electronic medical records (EMR) to identify potential candidates using databases (EPIC-based) from the University of Chicago and Ingalls. Participants will be identified by an initial screening of patients scheduled in EPIC for drug induced sleep endoscopy (DISE).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Phillip LoSavio, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillip LoSavio, MD, MS

CONTACT

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

Carlisa Dixon

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 19, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)