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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534076
Enrollment
303
Registered
2018-05-23
Start date
2018-06-01
Completion date
2023-11-30
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Sleep, Smoking

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.

Interventions

OTHERCohort Observational study

Cohort Observational study - there is no intervention

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 67 Years
Healthy volunteers
Yes

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. -

Design outcomes

Primary

MeasureTime frameDescription
FEV1/FVC ratio365 daysLung 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026