RECRUITING

Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-04

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06317701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Phillip LoSavio, MD, MS

CONTACT

773-702-5189

Phillip.Losavio@bsd.uchicago.edu

Carlisa Dixon

CONTACT

773-834-4337

cdixon520@bsd.uchicago.edu

Principal Investigator

Phillip LoSavio, MD, MS

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

The University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Phillip LoSavio, MD, MS, PRINCIPAL_INVESTIGATOR, University of Chicago

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

Study Start Date2024-04-04

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea