Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
Stopped early · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT03051165
- Run by
- Emory University
- People needed
- 13
- Starts
- 2016-11-21
- Expected to finish
- 2017-12-14
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English-speaking
- Able to give informed consent
- Have undergone implantation of hypoglossal nerve stimulator (HGNS) by the principal investigator of this study. HGNS inclusion criteria per FDA are as follows:
- Apnea-hypopnea index (AHI) of 20 or more from recent sleep test
- Unable to use positive airway pressure therapy
- Body Mass Index (BMI) < 32 kg/m2
- Without circumferential collapse on drug-induced sedated endoscopy
You may not qualify if…
- Active smokers
- Unstable and untreated coronary or peripheral artery disease
- Use of alpha-blockers
- Severe and inadequately controlled arterial hypertension
Where it is running
- Emory Sleep Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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