University StudentsNCT06954168
The Effects of Smoking on Sleep Quality, Fatigue and Perceived Stress
An observational study of University Students, run by Barış SEVEN.
Trial summary
Tobacco use is a major cause of death resulting from cancer, cardiovascular diseases, and pulmonary disorders. It is also a risk factor for respiratory and other infections, osteoporosis, diabetes, reproductive disorders, adverse surgical outcomes and delayed wound healing, as well as duodenal and gastric ulcers [1]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- University Students
- How many people
- 528 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2025to 27 Oct 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: University Students
Who may be able to join
- be an actively enrolled undergraduate student
Who cannot join
- Have a diagnosed sleep disorder such as sleep apnea, insomnia or narcolepsy.
- Have mental health problems such as diagnosed depression, anxiety disorders or bipolar disorder.
- Chronic diseases such as diabetes, hypertension, asthma.
- Conditions that may independently affect sleep, fatigue or stress, such as night shift work and pregnancy.
About this study
Official title: The Effects of Smoking on Sleep Quality, Fatigue and Perceived Stress in University Students: A Comparison Study
Tobacco use is a major cause of death resulting from cancer, cardiovascular diseases, and pulmonary disorders. It is also a risk factor for respiratory and other infections, osteoporosis, diabetes, reproductive disorders, adverse surgical outcomes and delayed wound healing, as well as duodenal and gastric ulcers [1]. Studies project that the number of deaths due to smoking will rise to 8.4 million by 2030 [2]. According to the Tobacco Atlas, in Turkey, 83,100 people die each year due to smoking-related causes.
The negative effects of smoking are not limited to chronic diseases; it can also affect the quality of daily life. In a study involving 3,516 participants, it was reported that both male and female smokers experienced significantly greater difficulty falling asleep compared to non-smokers. They also suffered from non-restorative sleep, frequent awakenings during the night, and difficulty falling back asleep [3]. Furthermore, literature has demonstrated a significant relationship between smoking and perceived stress [4]. Perceived stress is defined as "the feelings or thoughts an individual has about how much stress they are under during a particular period" [5]. Although smoking may temporarily alleviate perceived stress, studies suggest it may actually lead to negative emotional states or exacerbate stress in the long run [6, 7]. In addition, it has been found that smokers tend to feel more tired and become fatigued more quickly compared to non-smokers [8, 9].
Read more
The majority of smokers begin smoking during adolescence [10]. In their study, Burt et al. reported that 71% of smokers started smoking at or before the age of 18 [11]. The university period is a critical phase in young individuals' lives, and habits formed during this time can have long-term health consequences. Smoking can affect not only health but also academic performance [12]. Factors such as stress [13], sleep quality [14], and fatigue [15], which have previously been studied in smokers, have also been shown to negatively impact academic achievement. Although academic success will not be directly evaluated in our study, considering the target population, the potential secondary effect of smoking on academic performance further underscores the significance of our research.
This study is designed to compare university students who smoke and those who do not in terms of sleep quality, fatigue, and perceived stress levels. Although there are existing studies that examine these parameters individually or in different populations, to our knowledge, no study has simultaneously assessed all of these factors in a university student sample. Most studies in this field focus on the general population; however, university students represent a specific group due to their stressful academic lives, social pressures, and lifestyle changes. The originality of our study lies in its focus on university students and its comprehensive approach to examining multiple variables concurrently. In this context, the planned research will provide more specific and detailed insights into the factors associated with nicotine dependence and their interrelationships.
- Conditions
- University Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| University students who smoke | Not described | |
| non-smoking university students | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fagerstrom Test for Nicotine Dependence
Measured: only once
The Pittsburgh Sleep Quality Index Scoring
Measured: only once
The Fatigue Assessment Scale
Measured: only once
The Perceived Stress Scale
Measured: only once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start25 May 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion27 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barış SEVEN
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Barış SEVEN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954168
- Sponsor's protocol ID
- 7
- Status last verified
- Sep 2024
- First submitted
- 24 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Smoking on Sleep Quality, Fatigue and Perceived Stress in University Students: A Comparison Study
- ClinicalTrials.gov ID
- NCT06954168
- Acronym / sponsor ID
- 7
- Conditions
- University Students
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Barış SEVENUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 27 Oct 2025 (estimated)
- First posted
- 1 May 2025 (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.
Tobacco use is a major cause of death resulting from cancer, cardiovascular diseases, and pulmonary disorders. It is also a risk factor for respiratory and other infections, osteoporosis, diabetes, reproductive disorders, adverse surgical outcomes and delayed wound healing, as well as duodenal and gastric ulcers [1]. Studies project that the number of deaths due to smoking will rise to 8.4 million by 2030 [2]. According to the Tobacco Atlas, in Turkey, 83,100 people die each year due to smoking-related causes.
The negative effects of smoking are not limited to chronic diseases; it can also affect the quality of daily life. In a study involving 3,516 participants, it was reported that both male and female smokers experienced significantly greater difficulty falling asleep compared to non-smokers. They also suffered from non-restorative sleep, frequent awakenings during the night, and difficulty falling back asleep [3]. Furthermore, literature has demonstrated a significant relationship between smoking and perceived stress [4]. Perceived stress is defined as "the feelings or thoughts an individual has about how much stress they are under during a particular period" [5]. Although smoking may temporarily alleviate perceived stress, studies suggest it may actually lead to negative emotional states or exacerbate stress in the long run [6, 7]. In addition, it has been found that smokers tend to feel more tired and become fatigued more quickly compared to non-smokers [8, 9].
The majority of smokers begin smoking during adolescence [10]. In their study, Burt et al. reported that 71% of smokers started smoking at or before the age of 18 [11]. The university period is a critical phase in young individuals' lives, and habits formed during this time can have long-term health consequences. Smoking can affect not only health but also academic performance [12]. Factors such as stress [13], sleep quality [14], and fatigue [15], which have previously been studied in smokers, have also been shown to negatively impact academic achievement. Although academic success will not be directly evaluated in our study, considering the target population, the potential secondary effect of smoking on academic performance further underscores the significance of our research.
This study is designed to compare university students who smoke and those who do not in terms of sleep quality, fatigue, and perceived stress levels. Although there are existing studies that examine these parameters individually or in different populations, to our knowledge, no study has simultaneously assessed all of these factors in a university student sample. Most studies in this field focus on the general population; however, university students represent a specific group due to their stressful academic lives, social pressures, and lifestyle changes. The originality of our study lies in its focus on university students and its comprehensive approach to examining multiple variables concurrently. In this context, the planned research will provide more specific and detailed insights into the factors associated with nicotine dependence and their interrelationships.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| University students who smoke | – | – |
| non-smoking university students | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- University Students
Key inclusion criteria (1 listed)
- be an actively enrolled undergraduate student
Key exclusion criteria (4 listed)
- Have a diagnosed sleep disorder such as sleep apnea, insomnia or narcolepsy.
- Have mental health problems such as diagnosed depression, anxiety disorders or bipolar disorder.
- Chronic diseases such as diabetes, hypertension, asthma.
- Conditions that may independently affect sleep, fatigue or stress, such as night shift work and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Fagerstrom Test for Nicotine Dependence
Time frame: only once
The Pittsburgh Sleep Quality Index Scoring
Time frame: only once
The Fatigue Assessment Scale
Time frame: only once
The Perceived Stress Scale
Time frame: only once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of University Students, run by Barış SEVEN.
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 4 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The Fagerstrom Test for Nicotine Dependence (time frame: only once). The study lists 4 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 13 May 2025.