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临床试验/NCT03051165
NCT03051165终止不适用

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

Emory University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Change in Peripheral Arterial Tonometry (PAT)

研究概览

简要总结

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.

详细描述

Obstructive sleep apnea (OSA), the repetitive collapse of the upper airway during sleep, represents a growing individual and public health concern. This disease negatively impacts patients' sleep quality and daytime function, including an increased risk of motor vehicle accidents. Several large, longitudinal cohorts have consistently demonstrated deleterious effects of OSA on cardiovascular health, including elevated rates of incident hypertension, myocardial infarction and cerebrovascular accidents. The link between OSA and cardiovascular consequences can be largely explained by autonomic imbalance during repeated episodes of nocturnal airway obstruction. Compared to those without OSA, people with OSA have increased sympathetic activity when awake, with further elevation of both sympathetic activity and blood pressure during sleep. Multiple physiologic mechanisms are responsible for these autonomic changes during obstructive episodes including the interaction of baroreceptors, chemoreceptors and respiratory afferent receptors.

Positive airway pressure (PAP) serves as a pneumatic stent for the airway, maintaining airway patency and normoxia. PAP therapy has demonstrated consistent, meaningful reductions in sympathetic overactivity during wake and sleep. Although PAP therapy is highly efficacious, fewer than 50% of patients are adequately treated due to adherence difficulty. In 2014, the Federal Drug Administration approved hypoglossal nerve stimulation (HGNS) for the treatment of patients with moderate-severe OSA who are unable to adequately use PAP. This therapy has demonstrated stable, marked improvement in key polysomnography indices, sleepiness measures and functional outcomes, however, no study has examined cardiovascular endpoints of HGNS therapy in OSA patients.

The aim of this study is to evaluate the effect of HGNS therapy on autonomic and vascular function before, during and after treatment for OSA with HGNS. People 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 in the study will have blood drawn and vascular function measurements taken before the HGNS device is activated, during treatment, and after a temporary treatment withdrawal period. The researchers hypothesize that all aforementioned measurements will be significantly improved following HGNS therapy and return to baseline values following a therapy withdrawal period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Interpretation of all tests (sleep tests, ambulatory blood pressure monitoring, vascular test and blood tests) will be done by an outcomes assessor who is blinded to whether treatment is active or withheld at the time of testing.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Active smokers
  • •Unstable and untreated coronary or peripheral artery disease
  • •Use of alpha-blockers
  • •Severe and inadequately controlled arterial hypertension

研究组 & 干预措施

Hypoglossal Nerve Stimulation Treatment Withdrawal

Other

Recipients of hypoglossal nerve stimulation (HGNS) who agree to participate in the study will have additional tests done to monitor cardiovascular responses to HGNS therapy and the temporary withdrawal of treatment.

干预措施: Hypoglossal Nerve Stimulation Treatment Withdrawal (Device)

结局指标

主要结局

Change in Peripheral Arterial Tonometry (PAT)

时间窗: Baseline, Day 105, Day 137

Peripheral arterial tonometry (PAT) is a method for measuring endothelial dysfunction in a non-invasive way. Blood flow is measured in the fingertips following compression with an inflatable cuff on the upper arm. Participants will lay on their backs with a probe placed on the finger of each hand. The probes are attached to a computer that records finger blood flow. The finger probes will continuously record the blood flow in the fingertips for 10 minutes

次要结局

  • Change in 24-hour Ambulatory Blood Pressure(Baseline, Day 105, Day 137)
  • Change in Heat Shock Protein 70 (HSP70)(Baseline, Day 105, Day 137)
  • Change in C-reactive Protein(Baseline, Day 105, Day 137)
  • Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR)(Baseline, Day 105, Day 137)
  • Change in Flow Mediated Dilation(Baseline, Day 105, Day 137)
  • Change in Peripheral Arterial Stiffness(Baseline, Day 105, Day 137)
  • Change in Fibrin Degradation Products(Baseline, Day 105, Day 137)
  • Change in High Sensitivity Cardiac Troponin (HS-troponin)(Baseline, Day 105, Day 137)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raj Dedhia

Assistant Professor

Emory University

研究点 (1)

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