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