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

NCT ID: NCT03534076

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cohort Observational study

Cohort Observational study - there is no intervention

Intervention Type: OTHER

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. -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aditi Satti, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple University Health System

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33741321 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32333930 (View on PubMed)

Other Identifiers

1R01MD012734-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1183509

Identifier Type: -

Identifier Source: org_study_id