Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
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| ClinicalTrials.gov Identifier: NCT03534076 |
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Recruitment Status :
Recruiting
First Posted : May 23, 2018
Last Update Posted : April 27, 2022
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Sponsor:
Temple University
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Temple University
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Sleep Lung Diseases Smoking | Other: Cohort Observational study |
| Study Type : | Observational |
| Estimated Enrollment : | 480 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults |
| Actual Study Start Date : | June 1, 2018 |
| Estimated Primary Completion Date : | March 31, 2023 |
| Estimated Study Completion Date : | March 31, 2023 |
Resource links provided by the National Library of Medicine
Intervention Details:
- Other: Cohort Observational study
Cohort Observational study - there is no intervention
Primary Outcome Measures :
- FEV1/FVC ratio [ Time Frame: 365 days ]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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 67 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
Inclusion Criteria:
- Self-reported African American, White, or mixed ethnicity.
- 40 - 67 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.
Exclusion Criteria:
- 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. -
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534076
Contacts
| Contact: Freda Patterson, PhD | 302-831-6588 | fredap@udel.edu | |
| Contact: Rachel I Blair, MS | 215-707-1278 | rachel.blair@temple.edu |
Locations
| United States, Pennsylvania | |
| Temple University Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Rachel Blair, MS | |
| Contact rachel.blair@temple.edu | |
Sponsors and Collaborators
Temple University
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
| Principal Investigator: | Aditi Satti, MD | Temple University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Temple University |
| ClinicalTrials.gov Identifier: | NCT03534076 |
| Other Study ID Numbers: |
1183509 1R01MD012734-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 23, 2018 Key Record Dates |
| Last Update Posted: | April 27, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Diseases Respiratory Tract Diseases |