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

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Temple University

Status

Active, not recruiting

Conditions

Lung Diseases
Smoking
Sleep

Treatments

Other: Cohort Observational study

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03534076
1R01MD012734-01 (U.S. NIH Grant/Contract)
1183509

Details and patient eligibility

About

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.

Enrollment

303 patients

Sex

All

Ages

40 to 67 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Self-reported African American, White, or mixed ethnicity.
  2. 40 - 67 years.
  3. GOLD stage 0-3 as assessed by spirometry.
  4. No moderate-severe sleep disorders or use of sleep medication.
  5. Self-reported current cigarette smoker as defined by smoking one or more cigarettes in the last month.
  6. Able to communicate in English and provide written informed consent.

Exclusion criteria

  1. Self-reported ethnicity (in full or part) other than Black/African American or White.
  2. < 40 years of age.
  3. Not a current cigarette smoker (< 1 cigarette in last month).
  4. GOLD stage >3.
  5. Presents with a diagnosed moderate-severe sleep disorder
  6. Use of any sleep medication. -

Trial contacts and locations

1

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Central trial contact

Freda Patterson, PhD; Rachel I Blair, MS

Data sourced from clinicaltrials.gov

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