Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- FEV1/FVC ratio [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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 >3.
-
Presents with a diagnosed moderate-severe sleep disorder
-
Use of any sleep medication. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Temple University Health System | Philadelphia | Pennsylvania | United States | 19140 |
Sponsors and Collaborators
- Temple University
- National Institutes of Health (NIH)
- National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
- Principal Investigator: Aditi Satti, MD, Temple University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1183509
- 1R01MD012734-01