Obstructive Sleep ApneaNCT06317701
Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
An observational study of Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Hypoglossal Nerve Stimulation (HGNS)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects will be recruited from the Sleep Surgery Clinic of the Duchossois Center for Advanced Medicine (DCAM) in Hyde Park and Sleep Surgery Clinic of UChicago Medicine - Orland Park and Hinsdale.. We will take advantage of the electronic medical records (EMR) to identify potential candidates using databases (EPIC-based) from the University of Chicago and Ingalls. Participants will be identified by an initial screening of patients scheduled in EPIC for drug induced sleep endoscopy (DISE).
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Phillip LoSavio, MD, MS, 773-702-5189, Phillip.Losavio@bsd.uchicago.edu
Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu
About this study
Official title: Hgns: 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.
Read the 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
- Being tested
- Hypoglossal Nerve Stimulation (HGNS)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal Nerve Stimulation (HGNS)Device
Alternative therapy for Obstructive Sleep Apnea
| Study group | Role | What they receive |
|---|---|---|
| HGNS Therapy Participants | Individuals with sleep apnea treated by HGNS therapy. Receives: Device: Hypoglossal Nerve Stimulation (HGNS) | |
| patients with OSA and complete concentric airway collapse on DISE | By standard of care, patients undergoing evaluation for HGNS as an alternative therapy for OSA must undergo drug-induced sleep endoscopy (DISE) to confirm anterior-posterior airway collapse (APC) and rule out complete concentric airway collapse (CCC). Currently, no studies have described the cardiometabolic profiles of patients with OSA and CCC - a population that is both intolerant to PAP and ineligible for HGNS. participants with CCC on DISE will complete an identical set of measures as the APC group. Due to the presence of CCC, these participants will not undergo surgery and will only receive testing once. Data from these subjects will be compared against the baseline (pre-operative) data of the APC group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
measured by standard deviation (SD) of average blood glucose or % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
Mean systolic BP (daytime and nocturnal)
important mediators of cardiovascular outcomes
Measured: 24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
Glycemic variability
measured by standard deviation (SD) of % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
Secondary outcomes (15)
mean blood glucose levels
other glycemic metrics for the clinical care of diabetes to be followed.
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
mean ambulatory glucose excursions
glycemic metrics for the clinical care of diabetes will be followed
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
time blocks
glycemic metrics for the clinical care of diabetes will be followed
Measured: 24-h, day, night at baseline and after HGNS implant, acclimation, and tuning
Morning fasting insulin, including calculated insulin resistance (HOMA-IR)
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Mean norepinephrine levels
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Morning fasting blood glucose
markers of glucose metabolism
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Hemoglobin A1c
markers of glucose metabolism
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Insulin levels
markers of glucose metabolism
Measured: at baseline and after HGNS implant, acclimation, and tuning
c-peptide levels
markers of glucose metabolism
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile (triglycerides)
testing for signs of cardiovascular disease
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
heart rate indices by activity monitor
testing for signs of cardiovascular disease
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
sympathetic activity by plasma norepinephrine
to investigate its role as a mediator in cardiometabolic response to treatment
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Morning fasting insulin of c-peptide level
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile (HDL- cholesterol)
testing for signs of cardiovascular disease
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile ( LDL-cholesterol)
testing for signs of cardiovascular disease
Measured: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start4 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillip LoSavio, MD, MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317701
- Sponsor's protocol ID
- IRB23-1801
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hgns: Metabolic Endpoints For Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation
- ClinicalTrials.gov ID
- NCT06317701
- Acronym / sponsor ID
- IRB23-1801
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGNS Therapy Participants | – | Device: Hypoglossal Nerve Stimulation (HGNS)Individuals with sleep apnea treated by HGNS therapy. |
| patients with OSA and complete concentric airway collapse on DISE | – | –By standard of care, patients undergoing evaluation for HGNS as an alternative therapy for OSA must undergo drug-induced sleep endoscopy (DISE) to confirm anterior-posterior airway collapse (APC) and rule out complete concentric airway collapse (CCC). Currently, no studies have described the cardiometabolic profiles of patients with OSA and CCC - a population that is both intolerant to PAP and ineligible for HGNS. participants with CCC on DISE will complete an identical set of measures as the APC group. Due to the presence of CCC, these participants will not undergo surgery and will only receive testing once. Data from these subjects will be compared against the baseline (pre-operative) data of the APC group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will be recruited from the Sleep Surgery Clinic of the Duchossois Center for Advanced Medicine (DCAM) in Hyde Park and Sleep Surgery Clinic of UChicago Medicine - Orland Park and Hinsdale.. We will take advantage of the electronic medical records (EMR) to identify potential candidates using databases (EPIC-based) from the University of Chicago and Ingalls. Participants will be identified by an initial screening of patients scheduled in EPIC for drug induced sleep endoscopy (DISE).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal Nerve Stimulation (HGNS)Alternative therapy for Obstructive Sleep Apnea | Device | HGNS Therapy Participants |
Primary outcome
Glycemic variability
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
measured by standard deviation (SD) of average blood glucose or % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
Mean systolic BP (daytime and nocturnal)
Time frame: 24 hrs at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
important mediators of cardiovascular outcomes
Glycemic variability
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op
measured by standard deviation (SD) of % coefficient of variation (SD / mean glucose) on two-week continuous glucose monitor
15 secondary outcomes
mean blood glucose levels
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
mean ambulatory glucose excursions
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
time blocks
Time frame: 24-h, day, night at baseline and after HGNS implant, acclimation, and tuning
Morning fasting insulin, including calculated insulin resistance (HOMA-IR)
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Mean norepinephrine levels
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Morning fasting blood glucose
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Hemoglobin A1c
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Insulin levels
Time frame: at baseline and after HGNS implant, acclimation, and tuning
c-peptide levels
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile (triglycerides)
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
heart rate indices by activity monitor
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
sympathetic activity by plasma norepinephrine
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Morning fasting insulin of c-peptide level
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile (HDL- cholesterol)
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
fasting lipid profile ( LDL-cholesterol)
Time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-Op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phillip LoSavio, MD, MS principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip LoSavio, MD, MS (773-702-5189, Phillip.Losavio@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variability (time frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.