Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

NCT ID: NCT06317701

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2028-04-30

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.

Detailed Description

Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder in the general population. It is estimated that 80 percent of those who have OSA remain undiagnosed, and thus do not receive therapy. Strong evidence from epidemiologic and clinical studies suggests that untreated OSA is an independent risk factor for cardiometabolic disease, particularly among those with moderate-to-severe OSA. Animal and human models have revealed that intermittent hypoxia and sleep fragmentation (i.e., main features of OSA) result in insulin resistance, glucose intolerance and pancreatic beta-cell dysfunction, hypertension and dyslipidemia. Continuous positive airway pressure (CPAP) is the established first-line treatment for OSA. However, only 50% of patients with OSA are adherent to CPAP therapy. Notably, a key limitation of prior CPAP trials on cardiometabolic outcomes is low treatment adherence.

A randomized controlled trial conducted at the University of Chicago demonstrated that 8 hours of nightly CPAP reduces glucose response during oral glucose tolerance testing and improves insulin sensitivity in individuals with OSA and prediabetes. In 2014, following the pivotal Safe and Timely Antithrombotic Removal - Ticagrelor trial (STAR), the Food and Drug Administration (FDA) approved hypoglossal nerve stimulation (HNS) as an alternative therapy for OSA. Five-year outcomes from STAR have confirmed durable efficacy, tolerance, and safety for HNS. From improved tolerance and adherence, it is theorized that HNS may be more effective than CPAP at ameliorating cardiovascular and diabetes risk. Yet, there is no literature on the cardiometabolic outcomes of treating OSA with HNS.

The study team's long-term goal is to understand the metabolic and cardiovascular effects of OSA and how current therapies can mitigate risk and improve outcomes. The overall objective of this study is to determine the cardiometabolic impact of HNS therapy in patients with moderate-to-severe OSA who are intolerant to CPAP. It is hypothesized by the investigator that effective HNS treatment will improve glucose metabolism and markers of cardiovascular disease.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HGNS Therapy Participants

Individuals with sleep apnea treated by HGNS therapy.

Hypoglossal Nerve Stimulation (HGNS)

Intervention Type: DEVICE

Alternative therapy for Obstructive Sleep Apnea

Interventions

Hypoglossal Nerve Stimulation (HGNS)

Alternative therapy for Obstructive Sleep Apnea

Intervention Type: DEVICE

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
• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillip LoSavio, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Phillip LoSavio, MD, MS

Role: CONTACT

Phillip.Losavio@bsd.uchicago.edu

773-702-5189

Carlisa Dixon

Role: CONTACT

cdixon520@bsd.uchicago.edu

773-834-4337

Facility Contacts

Phillip LoSavio, MD, MS

Role: primary

Phillip.Losavio@bsd.uchicago.edu

773-702-5189

Leila Yazdanbakhsh

Role: backup

leila.yazdanbakhsh@bsd.uchicago.edu

773-834-5087

Other Identifiers

IRB23-1801

Identifier Type: -

Identifier Source: org_study_id