Who is eligible for clinical trial NCT06317701?

Participants must meet protocol criteria for Obstructive Sleep Apnea. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06317701 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-26

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation (NCT06317701)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University of Chicago

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (12 items).

Location: The University of Chicago — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The University of Chicago — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗