Clinical trial NCT03534076: Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
Official title: Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep
Lung Diseases
Smoking
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-05-23
Enrollment: 303
Sex: ALL
Minimum age (years): 40
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are 480 African American smokers and 80 White smokers who do not have a sleep disorder or GOLD stages 4 at intake.

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: FEV1/FVC ratio
timeFrame: 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Health System
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Aditi Satti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson F, Brewer B, Blair R, Grandner MA, Hoopes E, Ma G, Criner GJ, Satti A. An exploration of clinical, behavioral, and community factors associated with sleep duration and efficiency among middle-aged Black/African American smokers. Sleep Health. 2021 Jun;7(3):397-407. doi: 10.1016/j.sleh.2021.01.006. Epub 2021 Mar 16.
citation: Gangemi AJ, Satti A, Zantah M, Blair R, Brewer B, Ma G, Grandner MA, Davey A, Criner GJ, Patterson F. Sleep Duration and Efficiency Associated With Better Functional Exercise Capacity in Black Smokers at Risk for COPD. Chest. 2020 Oct;158(4):1680-1688. doi: 10.1016/j.chest.2020.03.070. Epub 2020 Apr 22.