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CompletedNCT06680570SHUSUpdated Nov 8, 2024

Smoking and Health Among University Students

An observational study in Pulmonary Disease, Headache Disorders and Sedentary Behavior, sponsored by University of Yalova. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by University of Yalova · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
163
Ages
18 Years to 30 Years
Sex
All
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Study 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. 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.

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.

02

Conditions studied

  • Pulmonary Disease
  • Headache Disorders
  • Sedentary Behavior
  • Physical Activity Level

Keywords

  • Smoking
  • Headache
  • Students
  • Sedentary behavior
03

In context

Lung Diseases

3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 163 is close to the median of 160 across 939 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University of Yalova is the lead sponsor of 58 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

young people

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Being Yalova University students Aged between18-30 years

Exclusion criteria

Exclusion Criteria:

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

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05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
163 participants (actual)
Target follow-up
10 Months
Patient registry
Yes

Groups and cohorts

  • 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.

    Diagnostic Test: Pulmonary Function Testing, Carbon Monoxide (CO) Breath Testing

Interventions

  • Diagnostic testPulmonary Function Testing, Carbon Monoxide (CO) Breath Testing

    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.

    Also known as: Headache Impact Test (HIT-6), Physical Activity Assessment (IPAQ-SF)

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What researchers measure

Primary outcomes

  1. Forced vital capacity (FVC)

    FVC spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.

    Time frame: 10 month

  2. Forced Expiratory Volume in 1 second (FEV1)

    FEV1 spirometry tests (liters) used to measure lung capacity among both smoker and non-smoker students.

    Time frame: 10 month

  3. Headache Impact Test (HIT-6)

    Headache Impact Test questionnaire used to assess the impact of headaches on daily life.

    Time frame: 10 month

  4. 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.

    Time frame: 10 month

  5. Carbon Monoxide (CO) Level

    Measurement of carbon monoxide levels (Part Pers Million (ppm)) in exhaled breath to assess exposure from smoking.

    Time frame: 10 month

07

Study locations

1 site
  • asuman SALTAN
    Yalova, 77200, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Aug 2021, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 8, 2024
StartActual
Jan 1, 2021
Primary completionActual
Aug 1, 2021
CompletionActual
Jan 1, 2022
Last update
Nov 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06680570
Lead sponsor
University of Yalova
Responsible party
Sponsor
First posted
Nov 8, 2024
Start date
Jan 1, 2021
Primary completion
Aug 1, 2021
Completion
Jan 1, 2022
Last update
Nov 8, 2024

Study contacts

asuman SALTAN
principal investigator · University of Yalova

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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