NCT06317701 Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
| NCT ID | NCT06317701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-04-04 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Phillip LoSavio, MD, MS
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06317701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06317701 currently recruiting?
Yes, NCT06317701 is actively recruiting participants. Contact the research team at Phillip.Losavio@bsd.uchicago.edu for enrollment information.
Where is the NCT06317701 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06317701 clinical trial?
NCT06317701 is sponsored by University of Chicago. The principal investigator is Phillip LoSavio, MD, MS at University of Chicago. The trial plans to enroll 30 participants.