Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
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.
Conditions:
🦠 Obstructive Sleep Apnea
🗓️ Study Start (Actual) 4 April 2024
🗓️ Primary Completion (Estimated) April 2028
✅ Study Completion (Estimated) April 2028
👥 Enrollment (Estimated) 30
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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
    • * Absent circumferential collapse on Drug-Induced Sleep Endoscopy (DISE)
    • * Not able to use positive airway pressure \>4 hours for 5 nights/week or unwilling to use positive airway pressure
    • * Weight stable (no change \>25 lbs in the past 3 months)

    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)
    • * Enrolled in a formal weight loss program or following an incompatible dietary regimen
    • * Current systemic steroid use
    • * Taking prescription medication or herbal remedy for weight loss
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 February 2024
  • First Submitted that Met QC Criteria 11 March 2024
  • First Posted 19 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024