NCT03051165

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

Terminated NA Results posted Last updated 11 December 2018

What this trial tests

NA trial testing Hypoglossal Nerve Stimulation Treatment Withdrawal in Obstructive Sleep Apnea in 13 participants. Terminated before completion.

Timeline

21 November 2016

Primary endpoint
14 December 2017

14 December 2017

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	21 November 2016
Primary completion	14 December 2017
Estimated completion	14 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Hypoglossal Nerve Stimulation Treatment Withdrawal

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Emory University

Who can join

18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Flow Mediated Dilation Secondary · Baseline, Day 105, Day 137

Flow mediated dilation is a method to assess endothelial function using an ultrasound device to take measurements of the artery at the elbow. Blood vessel diameter is measured before and after blood pressure cuff release and flow mediated dilation is the percent of change between the baseline and post cuff release measurements. A lower measurement of dilation corresponds with an increased risk for cardiovascular events.

Baseline (before initial device activation)

Group	Value	95% CI
Hypoglossal Nerve Stimulation Treatment Withdrawal	2.23	± 0.0

Day 105 (after 90 days of device activation)

Group	Value	95% CI
Hypoglossal Nerve Stimulation Treatment Withdrawal	4.75	± 0.0

Change in 24-hour Ambulatory Blood Pressure Secondary · Baseline, Day 105, Day 137

To measure 24-hour ambulatory blood pressure, participants wear a watch like device on one arm which records blood pressure throughout the day.

Baseline Visit Systolic Blood Pressure

Group	Value	95% CI
Hypoglossal Nerve Stimulation Treatment Withdrawal	133	± 0.0

Baseline Visit Diastolic Blood Pressure

Group	Value	95% CI
Hypoglossal Nerve Stimulation Treatment Withdrawal	67	± 0.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.