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临床试验/NCT04124848
NCT04124848招募中不适用

Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
600
试验地点
2
主要终点
To assess the prevalence of obstructive sleep apnea

研究概览

简要总结

The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

详细描述

Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Self-identify as Somali, African, Asian, and European descent.
  • •Adult males and females who are older than 18 years of age.

排除标准

  • •Minors under 18 years or adults over 100 years
  • •Positive pregnancy

研究组 & 干预措施

Somali Descent

Study participants who are of Somali origin.

Non-Somali Descent

Study participants who are not of Somali origin.

结局指标

主要结局

To assess the prevalence of obstructive sleep apnea

时间窗: 10 years

Measure the apnea-hypopnea index (AHI) to determine burden of obstructive sleep apnea. Based on the AHI, sleep apnea will be diagnosed if the AHI is ≥5 events/hour.

To determine the severity of obstructive sleep apnea

时间窗: 10 years

The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI \< 5 per hour, Mild: AHI ≥ 5, but \< 15 per hour, Moderate: AHI ≥ 15, but \< 30 per hour, Severe: AHI ≥ 30 per hour.

次要结局

  • Vascular endothelial function(10 years)
  • Insulin sensitivity(10 years)
  • 24 hour mean arterial pressure(10 years)
  • Body composition(10 years)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

研究点 (2)

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