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Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea

NCT03051165 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-12-11

Study results available
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Summary

This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study site will be told about the study at their 2-week post-operative appointment. Those who decide to participate will have blood drawn and vascular function measurements taken before HGNS activation, during treatment, and after a temporary treatment withdrawal period. Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.

Conditions

Interventions

DEVICE

Hypoglossal Nerve Stimulation Treatment Withdrawal

After 90 days of hypoglossal nerve stimulation (HGNS), therapy will be discontinued for 30 days before being reactivated.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Raj Dedhia, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2017-12-14
Completion
2017-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051165 on ClinicalTrials.gov