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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03534076
• Other study ID #: 1183509
• Secondary ID: 1R01MD012734-01
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 303
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 67 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Lung Diseases
• Sleep
• Smoking

Intervention

Other:
• Cohort Observational study
Cohort Observational study - there is no intervention

Locations

Country	Name	City	State
United States	Temple University Health System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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