RecruitingNCT06317701

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Hgns: Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Apr 4, 2024

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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