Cigarette AddictionNCT07131891
The Effects of Electronic Cigarette and Traditional Cigarette
An observational study of Cigarette Addiction, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate and compare the effects of traditional cigarette and e-cigarette consumption habits on sleep quality, fatigue, mental health and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Addiction
- What is being tested?
- Fatigue Severity Scale, Depression, Anxiety and Stress Scale-21 and Jenkins Sleep Scale
- How many people
- 533 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 1 Aug 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female individuals between the ages of 18-65
Who may be able to join
- Male and female individuals between the ages of 18-65
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Electronic Cigarette and Traditional Cigarette Consumption Habits on Sleep Quality, Fatigue, Mental Health, and Quality of Life
The aim of the study is to investigate and compare the effects of traditional cigarette and e-cigarette consumption habits on sleep quality, fatigue, mental health and quality of life.
Read the detailed description
E-cigarettes are battery-powered devices that vaporize a solution that may or may not contain nicotine. Carcinogens and other toxins in e-cigarettes can have negative effects on physical health, and their potential negative effects on mental health are also a concern. Adults in the US who experience serious psychological distress are reported to be more likely to use traditional cigarettes (tobacco), e-cigarettes, or both than adults without serious psychological distress. A relationship between traditional cigarette smoking and mental illness, including depression, is well-known. Recent studies have also found that depressive symptoms are associated with e-cigarette use. A study comparing the relationship between different cigarette products and depressive symptoms found that dual use (traditional cigarettes and e-cigarettes) in young adults was associated with higher depressive symptoms than single use.
Another mental health factor associated with smoking is sleep health. Nicotine is thought to be the primary mechanism linking traditional cigarette use to sleep disorders, as acute withdrawal during the night can cause uncomfortable and sleep-disrupting physiological symptoms. This relationship is also observed in e-cigarette users. In a study conducted with university students, e-cigarette users reported poorer sleep health compared to non-smokers.
Smoking and e-cigarette use are also known to affect fatigue and quality of life. Cao et al. evaluated non-smokers, traditional cigarette users, e-cigarette users, and dual users in terms of fatigue and quality of life. They reported that non-smokers had the lowest fatigue and highest quality of life among these four groups, while the e-cigarette user group had less fatigue and higher quality of life than the traditional cigarette user group.
Various studies in the literature compare e-cigarette and traditional cigarette users in terms of fatigue, sleep quality, depression, mental health, and quality of life. However, there are insufficient studies evaluating all parameters and investigating the relationships among these parameters. Therefore, we believe that our study will provide valuable contributions to the literature in this area.
Another mental health factor associated with smoking is sleep health. Nicotine is thought to be the mechanism linking traditional cigarette use to sleep disorders, as acute withdrawal during the night can cause uncomfortable and sleep-disrupting physiological symptoms. This relationship is also seen in e-cigarette users. In a study conducted with university students, e-cigarette users reported poorer sleep health compared to non-smokers. Smoking and e-cigarette use are also known to affect fatigue and quality of life. Cao et al. evaluated non-smokers, traditional cigarette users, e-cigarette users, and both in terms of fatigue and quality of life. They reported that non-smokers had the lowest fatigue and highest quality of life among these four groups. The e-cigarette user group had less fatigue and higher quality of life than the traditional cigarette user group. Various studies in the literature compare e-cigarette and traditional cigarette users in terms of fatigue, sleep quality, depression, mental health, and quality of life. However, there are insufficient studies evaluating all parameters and investigating their relationship with each other. Therefore, we believe our study will contribute to the literature in this area.
- Conditions
- Cigarette Addiction
- Being tested
- Fatigue Severity Scale, Depression, Anxiety and Stress Scale-21, Jenkins Sleep Scale, Epworth Sleepiness Scale, Short Form-36
- Keywords
- electronic cigarette, traditional ciagrette, Sleep Quality, Fatigue, Mental Health
- Medical subject headings
- Vaping, Sleep Initiation and Maintenance Disorders, Fatigue, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Severity ScaleOther
Individuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of nine questions, and participants are asked about their fatigue level over the past week. Questions are scored from 1 to 7 using a Likert-type scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree," with higher scores indicating greater agreement. The total score is calculated by taking the arithmetic mean of all items, with the highest possible score being 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability of the FSS in Turkish have been previously established.
Depression, Anxiety and Stress Scale-21Other
Also called DASS-21
The 21-item Depression, Anxiety, and Stress Scale (DASS-21) will be administered to assess individuals' levels of depression, anxiety, and stress. The original scale was developed by Lovibond with 42 items. Subsequently, Brown et al. validated a shorter form for the same purpose and created the 21-item DASS-21. The Turkish adaptation of the DASS-21 was conducted by Yılmaz et al. The scale measures three subscales-depression, anxiety, and stress-consisting of seven items each. It is a 4-point Likert-type scale, with 0 indicating "Does not apply to me," 1 "Applies to me somewhat," 2 "Generally applies to me," and 3 "Applies to me completely." All items are scored positively, and each subscale is categorized as normal, mild, moderate, severe, or very severe.
Jenkins Sleep ScaleOther
The Jenkins Sleep Scale consists of four questions that assess sleep problems over a four-week period. Each question is scored from 0 to 5, resulting in a total score ranging from 0 to 20, with higher scores indicating greater sleep disturbances.
Epworth Sleepiness ScaleOther
The Epworth Sleepiness Scale (ESS) was developed to assess daytime sleepiness. It consists of eight items, each scored from 0 to 3, yielding a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The Turkish version of the scale was validated for reliability and accuracy by İzci et al. in 2008..
Short Form-36Other
Quality of life will be assessed using the Turkish version of the Short Form-36 (SF-36). The SF-36 assesses quality of life under eight subscales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each subscale are calculated separately, ranging from 0 to 100, with higher scores indicating better health status. A total score is not calculated.
| Study group | Role | What they receive |
|---|---|---|
| Electronic cigarette | Electronic cigarette users Receives: Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36 | |
| Traditional cigarette | Traditional cigarette users Receives: Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36 | |
| Dual | Both electronic and traditional cigarette users Receives: Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36 | |
| Control | Those who do not use any tobacco products, whether electronic or traditional Receives: Other: Fatigue Severity Scale; Other: Depression, Anxiety and Stress Scale-21; Other: Jenkins Sleep Scale; Other: Epworth Sleepiness Scale; Other: Short Form-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Individuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of 9 questions. Participants are questioned about their level of fatigue over the past week. Questions are scored from 1 to 7. The Likert-type scale is used, with 1 point representing "strongly disagree" and 7 points representing "strongly agree," with higher scores indicating greater agreement. A net score is obtained by calculating the arithmetic mean of all questions. The highest possible score is 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability study of the FSS has been conducted in the Turkish language.
Measured: From enrollment to the end of the assessment period at 2 hours
Jenkins Sleep Scale
The Jenkins Sleep Scale consists of four questions that assess sleep problems over a 4-week period. Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.
Measured: From enrollment to the end of the assessment period at 2 hours
Secondary outcomes (3)
Depression, Anxiety, and Stress Scale (DASS 21)
The 21-item "Depression, Anxiety, and Stress Scale (DASS 21)" will be administered to determine individuals' depression, anxiety, and stress levels. The scale was first developed by Lovibond and Lovibond (12) with 42 items. Subsequently, Brown et al. (13) determined that a shorter form was valid enough to perform the same measurement, and the 21-item "Depression, Anxiety, and Stress Scale (DASS 21)" was created. Yılmaz et al. (14) adapted the DASS 21 into Turkish. The scale, which measures depression, stress, and anxiety subscales and consists of 21 questions with 7 items for each subscale, is a 4-point Likert-type scale (0: Does not apply to me, 1: Applies to me somewhat, 2: Generally applies to me, and 3: Applies to me completely). All items on the scale are scored positively, and each subscale is evaluated by classifying it as normal, mild, moderate, severe, and very severe.
Measured: From enrollment to the end of the assessment period at 2 hours
Epworth Sleepiness Scale
This scale was developed to assess daytime sleepiness. It consists of a total of eight items, with four different response options ranging from 0 to 3 for each item, and the total score ranges from 0 to 24. The higher the total score, the greater the individual's degree of daytime sleepiness. The scale's validity and reliability in Turkish was conducted by İzci et al. in 2008.
Measured: From enrollment to the end of the assessment period at 2 hours
Short Form-36
Quality of life was assessed using the Turkish version of the Short Form 36 (SF-36) (18). The SF-36 assesses quality of life under eight subscales: physical function, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty, and mental health. Scores for each subscale are calculated separately. Subscale scores range from 0 to 100, with higher scores indicating better health. A total score is not calculated.
Measured: From enrollment to the end of the assessment period at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 Mar 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette AddictionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Yilmaz, Atılım University
- Investigators
- Seval Yılmaz, PhD, Principal investigator, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131891
- Sponsor's protocol ID
- 6040102411- Cigarette
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electronic Cigarette and Traditional Cigarette Consumption Habits on Sleep Quality, Fatigue, Mental Health, and Quality of Life
- ClinicalTrials.gov ID
- NCT07131891
- Acronym / sponsor ID
- 6040102411- Cigarette
- Conditions
- Cigarette Addiction
- Keywords
- electronic cigarette, traditional ciagrette, Sleep Quality, Fatigue, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Aug 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.
The aim of the study is to investigate and compare the effects of traditional cigarette and e-cigarette consumption habits on sleep quality, fatigue, mental health and quality of life.
Detailed description
E-cigarettes are battery-powered devices that vaporize a solution that may or may not contain nicotine. Carcinogens and other toxins in e-cigarettes can have negative effects on physical health, and their potential negative effects on mental health are also a concern. Adults in the US who experience serious psychological distress are reported to be more likely to use traditional cigarettes (tobacco), e-cigarettes, or both than adults without serious psychological distress. A relationship between traditional cigarette smoking and mental illness, including depression, is well-known. Recent studies have also found that depressive symptoms are associated with e-cigarette use. A study comparing the relationship between different cigarette products and depressive symptoms found that dual use (traditional cigarettes and e-cigarettes) in young adults was associated with higher depressive symptoms than single use.
Another mental health factor associated with smoking is sleep health. Nicotine is thought to be the primary mechanism linking traditional cigarette use to sleep disorders, as acute withdrawal during the night can cause uncomfortable and sleep-disrupting physiological symptoms. This relationship is also observed in e-cigarette users. In a study conducted with university students, e-cigarette users reported poorer sleep health compared to non-smokers.
Smoking and e-cigarette use are also known to affect fatigue and quality of life. Cao et al. evaluated non-smokers, traditional cigarette users, e-cigarette users, and dual users in terms of fatigue and quality of life. They reported that non-smokers had the lowest fatigue and highest quality of life among these four groups, while the e-cigarette user group had less fatigue and higher quality of life than the traditional cigarette user group.
Various studies in the literature compare e-cigarette and traditional cigarette users in terms of fatigue, sleep quality, depression, mental health, and quality of life. However, there are insufficient studies evaluating all parameters and investigating the relationships among these parameters. Therefore, we believe that our study will provide valuable contributions to the literature in this area.
Another mental health factor associated with smoking is sleep health. Nicotine is thought to be the mechanism linking traditional cigarette use to sleep disorders, as acute withdrawal during the night can cause uncomfortable and sleep-disrupting physiological symptoms. This relationship is also seen in e-cigarette users. In a study conducted with university students, e-cigarette users reported poorer sleep health compared to non-smokers. Smoking and e-cigarette use are also known to affect fatigue and quality of life. Cao et al. evaluated non-smokers, traditional cigarette users, e-cigarette users, and both in terms of fatigue and quality of life. They reported that non-smokers had the lowest fatigue and highest quality of life among these four groups. The e-cigarette user group had less fatigue and higher quality of life than the traditional cigarette user group. Various studies in the literature compare e-cigarette and traditional cigarette users in terms of fatigue, sleep quality, depression, mental health, and quality of life. However, there are insufficient studies evaluating all parameters and investigating their relationship with each other. Therefore, we believe our study will contribute to the literature in this area.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Electronic cigarette | – | Other: Fatigue Severity Scale, Other: Depression, Anxiety and Stress Scale-21, Other: Jenkins Sleep Scale, Other: Epworth Sleepiness Scale, Other: Short Form-36Electronic cigarette users |
| Traditional cigarette | – | Other: Fatigue Severity Scale, Other: Depression, Anxiety and Stress Scale-21, Other: Jenkins Sleep Scale, Other: Epworth Sleepiness Scale, Other: Short Form-36Traditional cigarette users |
| Dual | – | Other: Fatigue Severity Scale, Other: Depression, Anxiety and Stress Scale-21, Other: Jenkins Sleep Scale, Other: Epworth Sleepiness Scale, Other: Short Form-36Both electronic and traditional cigarette users |
| Control | – | Other: Fatigue Severity Scale, Other: Depression, Anxiety and Stress Scale-21, Other: Jenkins Sleep Scale, Other: Epworth Sleepiness Scale, Other: Short Form-36Those who do not use any tobacco products, whether electronic or traditional |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female individuals between the ages of 18-65
Key inclusion criteria (1 listed)
- Male and female individuals between the ages of 18-65
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Fatigue Severity ScaleIndividuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of nine questions, and participants are asked about their fatigue level over the past week. Questions are scored from 1 to 7 using a Likert-type scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree," with higher scores indicating greater agreement. The total score is calculated by taking the arithmetic mean of all items, with the highest possible score being 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability of the FSS in Turkish have been previously established. | Other | Control, Dual, Electronic cigarette, Traditional cigarette |
| Depression, Anxiety and Stress Scale-21Also: DASS-21The 21-item Depression, Anxiety, and Stress Scale (DASS-21) will be administered to assess individuals' levels of depression, anxiety, and stress. The original scale was developed by Lovibond with 42 items. Subsequently, Brown et al. validated a shorter form for the same purpose and created the 21-item DASS-21. The Turkish adaptation of the DASS-21 was conducted by Yılmaz et al. The scale measures three subscales-depression, anxiety, and stress-consisting of seven items each. It is a 4-point Likert-type scale, with 0 indicating "Does not apply to me," 1 "Applies to me somewhat," 2 "Generally applies to me," and 3 "Applies to me completely." All items are scored positively, and each subscale is categorized as normal, mild, moderate, severe, or very severe. | Other | Control, Dual, Electronic cigarette, Traditional cigarette |
| Jenkins Sleep ScaleThe Jenkins Sleep Scale consists of four questions that assess sleep problems over a four-week period. Each question is scored from 0 to 5, resulting in a total score ranging from 0 to 20, with higher scores indicating greater sleep disturbances. | Other | Control, Dual, Electronic cigarette, Traditional cigarette |
| Epworth Sleepiness ScaleThe Epworth Sleepiness Scale (ESS) was developed to assess daytime sleepiness. It consists of eight items, each scored from 0 to 3, yielding a total score ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The Turkish version of the scale was validated for reliability and accuracy by İzci et al. in 2008.. | Other | Control, Dual, Electronic cigarette, Traditional cigarette |
| Short Form-36Quality of life will be assessed using the Turkish version of the Short Form-36 (SF-36). The SF-36 assesses quality of life under eight subscales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each subscale are calculated separately, ranging from 0 to 100, with higher scores indicating better health status. A total score is not calculated. | Other | Control, Dual, Electronic cigarette, Traditional cigarette |
Primary outcome
Fatigue Severity Scale
Time frame: From enrollment to the end of the assessment period at 2 hours
Individuals' fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of 9 questions. Participants are questioned about their level of fatigue over the past week. Questions are scored from 1 to 7. The Likert-type scale is used, with 1 point representing "strongly disagree" and 7 points representing "strongly agree," with higher scores indicating greater agreement. A net score is obtained by calculating the arithmetic mean of all questions. The highest possible score is 7. Scores of 4 and above indicate pathological fatigue. The validity and reliability study of the FSS has been conducted in the Turkish language.
Jenkins Sleep Scale
Time frame: From enrollment to the end of the assessment period at 2 hours
The Jenkins Sleep Scale consists of four questions that assess sleep problems over a 4-week period. Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.
3 secondary outcomes
Depression, Anxiety, and Stress Scale (DASS 21)
Time frame: From enrollment to the end of the assessment period at 2 hours
Epworth Sleepiness Scale
Time frame: From enrollment to the end of the assessment period at 2 hours
Short Form-36
Time frame: From enrollment to the end of the assessment period at 2 hours
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 27 Aug 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.
Seval Yılmaz, PhD principal investigator
Atılım 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 Cigarette Addiction, run by Atılım University 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 1 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 27 Aug 2025. 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?
Fatigue Severity Scale (time frame: From enrollment to the end of the assessment period at 2 hours). The study lists 2 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 27 Aug 2025.