Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06317701
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hypoglossal Nerve Stimulation (HGNS) — DEVICE
    Alternative therapy for Obstructive Sleep Apnea

Study Details

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.

Key Dates

Start date
Apr 4, 2024
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: HGNS Therapy Participants
    Individuals with sleep apnea treated by HGNS therapy.
  • Arm: 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.

Primary Outcome Measure

Glycemic variability [ Time Frame: at baseline and after HGNS implant, acclimation, and tuning at 3 month Post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Phillip LoSavio, MD, MS
[email protected]
773-702-5189
Leila Yazdanbakhsh
[email protected]
773-834-5087
Phillip LoSavio, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Chicago· Chicago, IL

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