Pulmonary DiseaseSHUSNCT06680570
Smoking and Health Among University Students
An observational study of Pulmonary Disease and Headache Disorders, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to explore the associations between pulmonary capacity, physical activity levels, and headache occurrence in university students aged 18-30, focusing on differences between smokers and non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Headache Disorders, Sedentary Behavior
- What is being tested?
- Pulmonary Function Testing, Carbon Monoxide (CO) Breath Testing
- How many people
- 163 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2022
- How long will I take part?
- 10 Months
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: young people
Who may be able to join
- Being Yalova University students Aged between18-30 years
Who cannot join
- Participants showing signs or diagnosed with respiratory conditions such as tuberculosis, post-tuberculosis lung disease, bronchial asthma, Chronic Obstructive Pulmonar Disease, or valvular heart disease were excluded
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary capacıty, physıcal actıvıty Level and Headaches in Smokers and Non-smokers: ınsıghts From a unıversıty Student Cohort
The goal of this observational study is to explore the associations between pulmonary capacity, physical activity levels, and headache occurrence in university students aged 18-30, focusing on differences between smokers and non-smokers. The main questions it aims to answer are:
Is there a relationship between pulmonary function (FEV1 and FVC measurements) and the frequency of headaches in university students? How do physical activity levels and sedentary behavior differ between smokers and non-smokers, and how do these factors correlate with headache prevalence? Researchers will compare smokers and non-smokers to see if smoking influences CO levels, sedentary behavior, and respiratory function, contributing to a higher incidence of headaches.
Read more
Participants will:
Complete pulmonary function tests using handheld spirometers to measure FEV1 and FVC.
Fill out the International Physical Activity Questionnaire (IPAQ-SF) to assess physical activity and sedentary behavior.
Use the Headache Impact Test (HIT-6) to evaluate headache impact on daily life. Provide carbon monoxide (CO) breath levels for analysis.
Read the detailed description
This observational study investigates the relationships between pulmonary function, physical activity levels, and headache prevalence in university students, with a specific focus on the impacts of smoking. Conducted at Yalova University in Turkey, the study includes a diverse cohort of students aged 18-30, separated into two groups: smokers and non-smokers. By examining the physical health profiles and lifestyle behaviors of these students, the research aims to understand how smoking might affect respiratory function, activity levels, and the incidence of headaches within this population.
Objectives
The primary objectives are:
To determine whether pulmonary function (measured through FEV1 and FVC) is associated with headache occurrence and severity.
To assess the difference in sedentary behavior and physical activity levels between smokers and non-smokers and how these factors correlate with headache prevalence.
To analyze how elevated carbon monoxide (CO) levels from smoking affect respiratory capacity and contribute to headache incidence.
Methods
The study employs a cross-sectional design and utilizes several standardized tools for data collection:
Pulmonary Function Tests (PFTs): FEV1 (Forced Expiratory Volume in 1 second) and FVC (Forced Vital Capacity) values are recorded using a handheld spirometer. These tests provide an objective measure of lung capacity, which may be impacted by smoking.
International Physical Activity Questionnaire (IPAQ-SF): This validated questionnaire is used to assess physical activity levels, categorizing participants into low, moderate, or high activity levels, while also measuring sedentary behavior.
Headache Impact Test (HIT-6): This self-reported tool is administered to gauge the impact of headaches on daily life, allowing researchers to classify headache severity and its interference with student activities.
CO Breath Test: To assess smoking intensity, CO levels are measured using a breath analyzer, providing a clear, quantifiable indication of recent exposure to cigarette smoke.
Study Population and Exclusion Criteria Participants include male and female students aged 18-30 who are non-smokers or regular smokers. Exclusion criteria include individuals with pre-existing respiratory or cardiovascular conditions, recent respiratory infections, or recent surgeries. Students with diagnosed respiratory diseases (e.g., COPD, asthma) are excluded to ensure a focus on otherwise healthy individuals within the target age range.
Expected Outcomes
The study hypothesizes that:
Reduced lung function (lower FEV1 and FVC values) correlates with an increased frequency and severity of headaches, particularly among smokers.
Higher CO levels in smokers will be associated with greater headache prevalence and lower physical activity levels.
Sedentary behavior will be more common among non-smokers and may contribute to an increased incidence of headaches in this subgroup.
Significance The findings of this study are anticipated to provide valuable insights into the health impacts of smoking on young adults, particularly within the context of respiratory and neurological health. By establishing correlations between smoking, lung function, physical activity, and headaches, the study aims to inform targeted interventions for university students. Future public health initiatives may benefit from these findings by addressing sedentary behavior and smoking habits as key factors affecting the well-being of young adults in educational settings.
- Being tested
- Pulmonary Function Testing, Carbon Monoxide (CO) Breath Testing
- Keywords
- Smoking, Headache, Students, Sedentary behavior
- Medical subject headings
- Lung Diseases, Headache Disorders, Sedentary Behavior, Smoking, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Function Testing, Carbon Monoxide (CO) Breath TestingDiagnostic test
Also called Headache Impact Test (HIT-6), Physical Activity Assessment (IPAQ-SF)
Pulmonary Function Testing FEV1 and FVC spirometry tests used to measure lung capacity among both smoker and non-smoker students.
Carbon Monoxide (CO) Breath Testing Measurements taken using a CO breath analyzer to assess CO levels in the smoker group.
Physical Activity Assessment (IPAQ-SF) The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students.
Headache Impact Test (HIT-6) HIT-6 questionnaire used to assess the impact of headaches on daily life.
| Study group | Role | What they receive |
|---|---|---|
| smokers | Group: smokers Smokers Description: This group consists of university students who smoke regularly. Lung capacity, physical activity levels, carbon monoxide (CO) breath values and headache frequency will be measured and evaluated. This group was included in the study to examine the effect of smoking on these health parameters.
Non-Smokers Description: This group consists of non-smoking university students. Lung capacity, physical activity levels and headache frequency of non-smokers will be measured and compared with the smoking group. This group was included to analyse the relationship between lung function and headache in non-smokers. Receives: Diagnostic Test: Pulmonary Function Testing, Carbon Monoxide (CO) Breath Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
FVC spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.
Measured: 10 month
Forced Expiratory Volume in 1 second (FEV1)
FEV1 spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.
Measured: 10 month
Headache Impact Test (HIT-6)
Headache Impact Test questionnaire used to assess the impact of headaches on daily life.
Measured: 10 month
Physical Activity Assessment (IPAQ-SF)
The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students.
Measured: 10 month
Carbon Monoxide (CO) Level
Measurement of carbon monoxide levels (Part Pers Million (ppm)) in exhaled breath to assess exposure from smoking.
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Cross-sectional
- Enrolment
- 163 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- asuman SALTAN, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680570
- Sponsor's protocol ID
- SFT
- Other IDs
- 2019/AP/0012
- Acronym
- SHUS
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary capacıty, physıcal actıvıty Level and Headaches in Smokers and Non-smokers: ınsıghts From a unıversıty Student Cohort
- ClinicalTrials.gov ID
- NCT06680570
- Acronym / sponsor ID
- SHUS / SFT
- Keywords
- Smoking, Headache, Students, Sedentary behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Nov 2024 (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.
The goal of this observational study is to explore the associations between pulmonary capacity, physical activity levels, and headache occurrence in university students aged 18-30, focusing on differences between smokers and non-smokers. The main questions it aims to answer are:
Is there a relationship between pulmonary function (FEV1 and FVC measurements) and the frequency of headaches in university students? How do physical activity levels and sedentary behavior differ between smokers and non-smokers, and how do these factors correlate with headache prevalence? Researchers will compare smokers and non-smokers to see if smoking influences CO levels, sedentary behavior, and respiratory function, contributing to a higher incidence of headaches.
Participants will:
Complete pulmonary function tests using handheld spirometers to measure FEV1 and FVC.
Fill out the International Physical Activity Questionnaire (IPAQ-SF) to assess physical activity and sedentary behavior.
Use the Headache Impact Test (HIT-6) to evaluate headache impact on daily life. Provide carbon monoxide (CO) breath levels for analysis.
Detailed description
This observational study investigates the relationships between pulmonary function, physical activity levels, and headache prevalence in university students, with a specific focus on the impacts of smoking. Conducted at Yalova University in Turkey, the study includes a diverse cohort of students aged 18-30, separated into two groups: smokers and non-smokers. By examining the physical health profiles and lifestyle behaviors of these students, the research aims to understand how smoking might affect respiratory function, activity levels, and the incidence of headaches within this population.
Objectives
The primary objectives are:
To determine whether pulmonary function (measured through FEV1 and FVC) is associated with headache occurrence and severity.
To assess the difference in sedentary behavior and physical activity levels between smokers and non-smokers and how these factors correlate with headache prevalence.
To analyze how elevated carbon monoxide (CO) levels from smoking affect respiratory capacity and contribute to headache incidence.
Methods
The study employs a cross-sectional design and utilizes several standardized tools for data collection:
Pulmonary Function Tests (PFTs): FEV1 (Forced Expiratory Volume in 1 second) and FVC (Forced Vital Capacity) values are recorded using a handheld spirometer. These tests provide an objective measure of lung capacity, which may be impacted by smoking.
International Physical Activity Questionnaire (IPAQ-SF): This validated questionnaire is used to assess physical activity levels, categorizing participants into low, moderate, or high activity levels, while also measuring sedentary behavior.
Headache Impact Test (HIT-6): This self-reported tool is administered to gauge the impact of headaches on daily life, allowing researchers to classify headache severity and its interference with student activities.
CO Breath Test: To assess smoking intensity, CO levels are measured using a breath analyzer, providing a clear, quantifiable indication of recent exposure to cigarette smoke.
Study Population and Exclusion Criteria Participants include male and female students aged 18-30 who are non-smokers or regular smokers. Exclusion criteria include individuals with pre-existing respiratory or cardiovascular conditions, recent respiratory infections, or recent surgeries. Students with diagnosed respiratory diseases (e.g., COPD, asthma) are excluded to ensure a focus on otherwise healthy individuals within the target age range.
Expected Outcomes
The study hypothesizes that:
Reduced lung function (lower FEV1 and FVC values) correlates with an increased frequency and severity of headaches, particularly among smokers.
Higher CO levels in smokers will be associated with greater headache prevalence and lower physical activity levels.
Sedentary behavior will be more common among non-smokers and may contribute to an increased incidence of headaches in this subgroup.
Significance The findings of this study are anticipated to provide valuable insights into the health impacts of smoking on young adults, particularly within the context of respiratory and neurological health. By establishing correlations between smoking, lung function, physical activity, and headaches, the study aims to inform targeted interventions for university students. Future public health initiatives may benefit from these findings by addressing sedentary behavior and smoking habits as key factors affecting the well-being of young adults in educational settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smokers | – | Diagnostic Test: Pulmonary Function Testing, Carbon Monoxide (CO) Breath TestingGroup: smokers Smokers Description: This group consists of university students who smoke regularly. Lung capacity, physical activity levels, carbon monoxide (CO) breath values and headache frequency will be measured and evaluated. This group was included in the study to examine the effect of smoking on these health parameters. Non-Smokers Description: This group consists of non-smoking university students. Lung capacity, physical activity levels and headache frequency of non-smokers will be measured and compared with the smoking group. This group was included to analyse the relationship between lung function and headache in non-smokers. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young people
Key inclusion criteria (1 listed)
- Being Yalova University students Aged between18-30 years
Key exclusion criteria (2 listed)
- Participants showing signs or diagnosed with respiratory conditions such as tuberculosis, post-tuberculosis lung disease, bronchial asthma, Chronic Obstructive Pulmonar Disease, or valvular heart disease were excluded
- -
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 |
|---|---|---|
| Pulmonary Function Testing, Carbon Monoxide (CO) Breath TestingAlso: Headache Impact Test (HIT-6), Physical Activity Assessment (IPAQ-SF)Pulmonary Function Testing FEV1 and FVC spirometry tests used to measure lung capacity among both smoker and non-smoker students. Carbon Monoxide (CO) Breath Testing Measurements taken using a CO breath analyzer to assess CO levels in the smoker group. Physical Activity Assessment (IPAQ-SF) The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students. Headache Impact Test (HIT-6) HIT-6 questionnaire used to assess the impact of headaches on daily life. | Diagnostic test | smokers |
Primary outcome
Forced vital capacity (FVC)
Time frame: 10 month
FVC spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 10 month
FEV1 spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.
Headache Impact Test (HIT-6)
Time frame: 10 month
Headache Impact Test questionnaire used to assess the impact of headaches on daily life.
Physical Activity Assessment (IPAQ-SF)
Time frame: 10 month
The International Physical Activity Questionnaire Short Form (IPAQ-SF) used to evaluate physical activity levels and sedentary behavior among students.
Carbon Monoxide (CO) Level
Time frame: 10 month
Measurement of carbon monoxide levels (Part Pers Million (ppm)) in exhaled breath to assess exposure from smoking.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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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.
asuman SALTAN principal investigator
University of Yalova
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 Pulmonary Disease and Headache Disorders, run by University of Yalova at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Nov 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced vital capacity (FVC) (time frame: 10 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.