Effects of hypoglossal nerve stimulation on glucose metabolism in obstructive sleep apnea
Hgns: Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
This study is testing if a treatment called hypoglossal nerve stimulation can help improve blood sugar levels and heart health in overweight or obese adults with obstructive sleep apnea who can't or don't want to use CPAP therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06317701 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate whether hypoglossal nerve stimulation (HGNS) can improve glucose metabolism and cardiovascular predictors in patients with obstructive sleep apnea (OSA). The study will include overweight or obese adults diagnosed with OSA who are unable or unwilling to adhere to continuous positive airway pressure (CPAP) therapy. Participants will undergo assessments to measure changes in metabolic and cardiovascular outcomes following HGNS treatment. The findings could provide insights into the broader health implications of OSA treatment beyond sleep quality.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults aged 18 and older with diagnosed obstructive sleep apnea who cannot adhere to CPAP therapy.
Not a fit: Patients with insulin-dependent diabetes or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve metabolic health and reduce cardiovascular risks in patients with obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promising results for hypoglossal nerve stimulation in improving outcomes for obstructive sleep apnea, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Phillip LoSavio, MD, MS — University of Chicago
- Study coordinator: Phillip LoSavio, MD, MS
- Email: Phillip.Losavio@bsd.uchicago.edu
- Phone: 773-702-5189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.