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临床试验/NCT03534076
NCT03534076进行中(未招募)不适用

Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults

Temple University1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
303
试验地点
1
主要终点
FEV1/FVC ratio

研究概览

简要总结

This 5-year prospective, observational study will: (1) determine the individual, social, and environmental predictors of sleep duration, quality, latency, efficiency, timing and regularity in African American smokers, (2) quantify the prospective relationship between multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking is defined, and (3) examine the extent to which short sleep (<7 hrs) and other unhealthy sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480 African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study subjects will be recruited via Temple Health System sites. Following eligibility screening, initially eligible subjects will provide written study consent and complete an in-home sleep assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep disorders. Consenting and eligible subjects will be entered into the study and across the 60-month data collection period, complete 8 assessments: 4 annual clinical based assessments, interspersed by 4 mid-year, phone-based, self-report assessments.

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
40 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported African American, White, or mixed ethnicity.
  • 40 - 67 years.
  • GOLD stage 0-3 as assessed by spirometry.
  • No moderate-severe sleep disorders or use of sleep medication.
  • Self-reported current cigarette smoker as defined by smoking one or more cigarettes in the last month.
  • Able to communicate in English and provide written informed consent.

排除标准

  • Self-reported ethnicity (in full or part) other than Black/African American or White.
  • < 40 years of age.
  • Not a current cigarette smoker (< 1 cigarette in last month).
  • GOLD stage >
  • Presents with a diagnosed moderate-severe sleep disorder
  • Use of any sleep medication. -

结局指标

主要结局

FEV1/FVC ratio

时间窗: 365 days

Lung function as defined as the ratio of Forced Expiration Volume in one second (FEV1) to the Forced Vital Capacity (FVC; FEV1/FVC ratio) will be computed

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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