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

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ClinicalTrials.gov Identifier: NCT03534076
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Temple University

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

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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 :
  1. 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 65 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 who do not have a sleep disorder or GOLD stages 3-4 at intake.
Criteria

Inclusion Criteria:

  1. Self-reported African American ethnicity, or mixed ethnicity.
  2. 40 - 65 years.
  3. GOLD stage 0-2 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.
  2. < 40 years of age.
  3. Not a current cigarette smoker (< 1 cigarette in last month).
  4. GOLD stage >2.
  5. Presents with a diagnosed moderate-severe sleep disorder
  6. 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
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Contact: Freda Patterson, PhD 302-831-6588 fredap@udel.edu

Locations
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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
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Principal Investigator: Aditi Satti, MD Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03534076     History of Changes
Other Study ID Numbers: 1183509
1R01MD012734-01 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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