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HGNS Therapy Participants for Obstructive Sleep Apnea
N/A
Recruiting
Led By Phillip LoSavio, MD, MS
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and after hgns implant, acclimation, and tuning at 3 month post-op
Awards & highlights
Study 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.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and after hgns implant, acclimation, and tuning at 3 month post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and after hgns implant, acclimation, and tuning at 3 month post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic variability
Mean systolic BP (daytime and nocturnal)
Secondary outcome measures
Hemoglobin A1c
Insulin levels
Mean norepinephrine levels
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HGNS Therapy ParticipantsExperimental Treatment1 Intervention
Individuals with sleep apnea treated by HGNS therapy.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,747 Total Patients Enrolled
Phillip LoSavio, MD, MSPrincipal InvestigatorUniversity of Chicago
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