Effects of hypoglossal nerve stimulation on glucose metabolism in obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.