E Cigarette UseNCT07882407
A Behavioral Circuit Breathing Training Intervention on Smoking Cessation and Respiratory Function Among Youth Who Use E-cigarettes
A study testing Circuit Breathing Intervention and Diaphragmatic Breathing in people with E Cigarette Use, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study aims to evaluate the effects of a six-week behavioral circuit breathing training intervention on smoking cessation and respiratory function compared with diaphragmatic breathing training and usual daily activities Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- E Cigarette Use
- What is being tested?
- Circuit Breathing Intervention and Diaphragmatic Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female, aged 15-25 years.
- Regular e-cigarette use for at least 6 months and current e-cigarette use, defined as using e-cigarettes at least 1 day per week or at least 10 puffs per day during the past 30 days.
- No regular exercise during the 6 months prior to the study, defined as exercising fewer than 2 times per week.
- Willing and able to cooperate, with no communication difficulties, and able to follow the instructor's instructions.
- No history of heart disease or respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD).
- No hypertension, or controlled hypertension with resting blood pressure not exceeding a systolic blood pressure of 140 mmHg and a diastolic blood pressure of 90 mmHg (Whelton et al., 2018).
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- Able to move independently without assistance from another person or the use of assistive devices.
- Voluntarily agrees to participate in the study and is willing to sign the informed consent form.
- For participants younger than 18 years, consent must also be obtained from a legally authorized representative or parent/guardian.
Who cannot join
- An unforeseen circumstance prevents them from continuing participation in the study, such as an accidental injury or illness.
- Unable to participate consistently in the breathing training program as required, defined as attending fewer than 80% of all scheduled training sessions. Participants must attend at least 15 sessions.
- No longer willing to continue participating in the study.
- Concurrent use of illegal drugs or other tobacco or nicotine products, such as conventional cigarettes, waterpipe tobacco (hookah), hand-rolled tobacco, e-cigarette liquids, or other nicotine-containing products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Sports Science, Chulalongkorn University
Bangkok, Bangkok, 10330
Wannaporn Tongtako, Ph.D., 0879823131, wannaporn.t@chula.ac.th
About this study
Official title: Effects of Circuit Breathing Exercise-Based Behavioral Innovation on Smoking Cessation and Respiratory Function Among Youth E-Cigarette Users
This study aims to evaluate the effects of a six-week behavioral circuit breathing training intervention on smoking cessation and respiratory function compared with diaphragmatic breathing training and usual daily activities
Read the detailed description
A three-arm experimental study will include 45 male and female e-cigarette users aged 15-25 years, randomly allocated to a behavioral circuit breathing training group (n = 15), a diaphragmatic breathing training group (n = 15), or a control group (n = 15) that maintains usual daily activities. The two intervention groups will perform their respective breathing training programs three days per week for six weeks. Outcomes will be assessed before and after the intervention.
- Conditions
- E Cigarette Use
- Being tested
- Circuit Breathing Intervention, Diaphragmatic Breathing
- Keywords
- Smoking cessation, Respiratory function, Circuit breathing, Peak nasal inspiratory flow
- Medical subject headings
- Vaping, Smoking Cessation, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit Breathing InterventionOther
The circuit breathing intervention consists of five stations: paper suction using a straw, blowing a toy pinwheel, incentive spirometry, balloon blowing, and weighted diaphragmatic breathing. Participants will rest for 1 minute between stations.
Diaphragmatic BreathingOther
Participants will begin by breathing normally for 1 minute before starting diaphragmatic breathing. The diaphragmatic breathing exercise will consist of inhaling through the nose for 4 seconds and exhaling through the nose for 6 seconds, continuously for 10 minutes per set. Participants will rest for 1 minute between sets and complete a total of 3 sets.
| Study group | Role | What they receive |
|---|---|---|
| Circuit Breathing | Experimental | Not described Receives: Other: Circuit Breathing Intervention |
| Diaphragmatic breathing | Experimental | Not described Receives: Other: Diaphragmatic Breathing |
| Control group (Normal daily life) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Craving Questionnaire-Short Form (TCQ-SF) Score
Craving will be assessed using the 12-item TCQ-SF. The questionnaire is a self-report measure using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater tobacco craving.
Measured: Change from baseline Tobacco Craving Questionnaire-Short Form (TCQ-SF) score at 6 weeks.
Smoking Cessation Status and Behaviors
This self-report questionnaire consists of seven items assessing 7-day point-prevalence abstinence, duration of smoking cessation, smoking cessation behaviors, and attempts to quit smoking.
Measured: Change from baseline smoking cessation status and behaviors at 6 weeks.
Penn State Electronic Cigarette Dependence Index Score
E-cigarette dependence will be assessed using the Penn State Electronic Cigarette Dependence Index. The scale consists of 10 items, with a maximum total score of 20.
Measured: Change from baseline Penn State Electronic Cigarette Dependence Index score at 6 weeks.
Pulmonary function (Forced Expiratory Volume in one second; FEV1)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).
Measured: Change from baseline FEV1 at 6 weeks.
Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).
Measured: Change from baseline FEV1/FVC at 6 weeks.
Pulmonary function (Maximal voluntary ventilation; MVV)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).
Measured: Change from baseline MVV at 6 weeks.
Pulmonary function (Forced expiratory flow at 25-75%)
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver.
Measured: Change from baseline FEF 25-75% at 6 weeks.
Respiratory muscle strength
Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.
Measured: Change from baseline Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) at 6 weeks.
Secondary outcomes (5)
WHOQOL-BREF Score
Quality of life will be assessed using the World Health Organization Quality of Life questionnaire (WHOQOL). Participants will complete the 26-item questionnaire independently using an electronic device through Google Forms. Completion will take approximately 10 minutes.
Measured: Change from baseline WHOQOL-BREF Score at 6 weeks.
Pittsburgh Sleep Quality Index (PSQI) Global Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Participants will complete the 19-item questionnaire independently using an electronic device through Google Forms. Completion will take approximately 10 minutes.
Measured: Change from baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at 6 weeks.
Fractional Exhaled Nitric Oxide (FeNO)
Fractional exhaled nitric oxide (FeNO) will be measured using a device equipped with a bacterial filter and mouthpiece. Participants will place their lips around the mouthpiece and exhale into the device for 6 seconds while maintaining the indicator ball within the designated range. Results will be recorded in parts per million (ppm). The procedure will take approximately 5 minutes.
Measured: Change from baseline FeNO level (ppm) at 6 weeks.
Peak Nasal Inspiratory Flow (PNIF)
Peak nasal inspiratory flow will be measured using a peak nasal inspiratory flow meter. Participants will perform the breathing maneuver according to the study procedure, and the measurement will be recorded in liters per second (L/s).
Measured: Change from baseline PNIF (L/s) at 6 weeks.
Aerobic Fitness (Maximum oxygen consumption; VO2max)
Aerobic fitness will be assessed using a 3-minute step test. Participants will step up and down in time with an audible metronome for 3 minutes.
Measured: Change from baseline VO2max at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Cigarette UseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wannaporn Tongtako, Ph.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882407
- Sponsor's protocol ID
- EX PHYSIO SPSC 15
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Circuit Breathing Exercise-Based Behavioral Innovation on Smoking Cessation and Respiratory Function Among Youth E-Cigarette Users
- ClinicalTrials.gov ID
- NCT07882407
- Acronym / sponsor ID
- EX PHYSIO SPSC 15
- Conditions
- E Cigarette Use
- Keywords
- Smoking cessation, Respiratory function, Circuit breathing, Peak nasal inspiratory flow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Oct 2026 (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 study aims to evaluate the effects of a six-week behavioral circuit breathing training intervention on smoking cessation and respiratory function compared with diaphragmatic breathing training and usual daily activities
Detailed description
A three-arm experimental study will include 45 male and female e-cigarette users aged 15-25 years, randomly allocated to a behavioral circuit breathing training group (n = 15), a diaphragmatic breathing training group (n = 15), or a control group (n = 15) that maintains usual daily activities. The two intervention groups will perform their respective breathing training programs three days per week for six weeks. Outcomes will be assessed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circuit Breathing | Experimental | Other: Circuit Breathing Intervention |
| Diaphragmatic breathing | Experimental | Other: Diaphragmatic Breathing |
| Control group (Normal daily life) | No intervention | – |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male or female, aged 15-25 years.
- Regular e-cigarette use for at least 6 months and current e-cigarette use, defined as using e-cigarettes at least 1 day per week or at least 10 puffs per day during the past 30 days.
- No regular exercise during the 6 months prior to the study, defined as exercising fewer than 2 times per week.
- Willing and able to cooperate, with no communication difficulties, and able to follow the instructor's instructions.
- No history of heart disease or respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD).
Key exclusion criteria (4 listed)
- An unforeseen circumstance prevents them from continuing participation in the study, such as an accidental injury or illness.
- Unable to participate consistently in the breathing training program as required, defined as attending fewer than 80% of all scheduled training sessions. Participants must attend at least 15 sessions.
- No longer willing to continue participating in the study.
- Concurrent use of illegal drugs or other tobacco or nicotine products, such as conventional cigarettes, waterpipe tobacco (hookah), hand-rolled tobacco, e-cigarette liquids, or other nicotine-containing products.
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 |
|---|---|---|
| Circuit Breathing InterventionThe circuit breathing intervention consists of five stations: paper suction using a straw, blowing a toy pinwheel, incentive spirometry, balloon blowing, and weighted diaphragmatic breathing. Participants will rest for 1 minute between stations. | Other | Circuit Breathing |
| Diaphragmatic BreathingParticipants will begin by breathing normally for 1 minute before starting diaphragmatic breathing. The diaphragmatic breathing exercise will consist of inhaling through the nose for 4 seconds and exhaling through the nose for 6 seconds, continuously for 10 minutes per set. Participants will rest for 1 minute between sets and complete a total of 3 sets. | Other | Diaphragmatic breathing |
Primary outcome
Tobacco Craving Questionnaire-Short Form (TCQ-SF) Score
Time frame: Change from baseline Tobacco Craving Questionnaire-Short Form (TCQ-SF) score at 6 weeks.
Craving will be assessed using the 12-item TCQ-SF. The questionnaire is a self-report measure using a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater tobacco craving.
Smoking Cessation Status and Behaviors
Time frame: Change from baseline smoking cessation status and behaviors at 6 weeks.
This self-report questionnaire consists of seven items assessing 7-day point-prevalence abstinence, duration of smoking cessation, smoking cessation behaviors, and attempts to quit smoking.
Penn State Electronic Cigarette Dependence Index Score
Time frame: Change from baseline Penn State Electronic Cigarette Dependence Index score at 6 weeks.
E-cigarette dependence will be assessed using the Penn State Electronic Cigarette Dependence Index. The scale consists of 10 items, with a maximum total score of 20.
Pulmonary function (Forced Expiratory Volume in one second; FEV1)
Time frame: Change from baseline FEV1 at 6 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).
Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)
Time frame: Change from baseline FEV1/FVC at 6 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).
Pulmonary function (Maximal voluntary ventilation; MVV)
Time frame: Change from baseline MVV at 6 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).
Pulmonary function (Forced expiratory flow at 25-75%)
Time frame: Change from baseline FEF 25-75% at 6 weeks.
The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver.
Respiratory muscle strength
Time frame: Change from baseline Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) at 6 weeks.
Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.
5 secondary outcomes
WHOQOL-BREF Score
Time frame: Change from baseline WHOQOL-BREF Score at 6 weeks.
Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Change from baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at 6 weeks.
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Change from baseline FeNO level (ppm) at 6 weeks.
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Change from baseline PNIF (L/s) at 6 weeks.
Aerobic Fitness (Maximum oxygen consumption; VO2max)
Time frame: Change from baseline VO2max at 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit Breathing Intervention and Diaphragmatic Breathing in people with E Cigarette Use, run by Chulalongkorn University at 1 site in Thailand.
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 9 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wannaporn Tongtako, Ph.D. (0879823131, wannaporn.t@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Craving Questionnaire-Short Form (TCQ-SF) Score (time frame: Change from baseline Tobacco Craving Questionnaire-Short Form (TCQ-SF) score at 6 weeks.). The study lists 8 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 20 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.