Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317701
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-28
Brief Title:
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Hgns Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 teams 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
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 teams 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None