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

NCT03534076 | Unknown DMC

• 2 other identifiers: 11835091R01MD012734-01
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Lung Diseases; Smoking

Outcome Measures

Primary Outcomes (1)

• FEV1/FVC ratio

  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

  365 days

Interventions

Cohort Observational study OTHER

Cohort Observational study - there is no intervention

Eligibility Criteria

• Age: 40 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Self-reported African American, White, or mixed ethnicity.
• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Temple University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Temple University Health System

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

• 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.

  PMID: 33741321 DERIVED

• 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.

  PMID: 32333930 DERIVED

MeSH Terms

Conditions

Lung Diseases; Smoking

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Behavior

Study Officials

• Aditi Satti, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 23, 2018
• Study Start: June 1, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)