Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Recruiting now
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT06317701
- Run by
- University of Chicago
- People needed
- 30
- Starts
- 2024-04-04
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- The University of Chicago — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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