SleepNCT03534076
Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
An observational study of Sleep and Lung Diseases, run by Temple University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Lung Diseases, Smoking
- What is being tested?
- Cohort Observational study
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Health System
Philadelphia, Pennsylvania, 19140
About this study
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
- Being tested
- Cohort Observational study
- Medical subject headings
- Lung Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort Observational studyOther
Cohort Observational study - there is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jun 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Aditi Satti, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534076
- Sponsor's protocol ID
- 1183509
- Other IDs
- 1R01MD012734-01
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33741321Gangemi 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.
PubMed 32333930
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
- ClinicalTrials.gov ID
- NCT03534076
- Acronym / sponsor ID
- 1183509
- Conditions
- Sleep, Lung Diseases, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort Observational studyCohort Observational study - there is no intervention | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 33741321Patterson 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.
- Derived from this study: PubMed 32333930Gangemi 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.
- Individual participant dataSharing planned: Undecided
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditi Satti, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Lung Diseases, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1/FVC ratio (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.