Tobacco SmokingNCT07236580
Buteyko Breathing and Approach of Smoking Hygiene: Effects on Dysfucntion of Eustachian Tube and Lung Functions
A study testing Buteyko breathing plus smoking hyeigne approach and smoking hygiene appraoch in people with Tobacco Smoking and Eustachian Tube Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
adolescents are usually exposed to tobacco smoke passively. this can reduce their lung functions and negatively impact functions of Eustachian tube. The solution is to lower rates to tobacco exposure and use the support of Buteyko Breathing Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Tobacco Smoking, Eustachian Tube Dysfunction
- What is being tested?
- Buteyko breathing plus smoking hyeigne approach and smoking hygiene appraoch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 15 Jun 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dysfucntion of Eustachian Tube (obstructive chronic form)
- adolescents with passive tobacco exposure from smoking parent or household member
- adolscent participants whose parents approve the participation
Who cannot join
- cardiac problem
- chest disease
- renal/hepatic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: Is There Efficacy of Adding Buteyko Breathing to Approach of Smoking Hygiene on Dysfucntion of Eustachian Tube and Lung Functions in Adolescnets Who Are Passively Exposed to Tobacco Smoke?
adolescents are usually exposed to tobacco smoke passively. this can reduce their lung functions and negatively impact functions of Eustachian tube. The solution is to lower rates to tobacco exposure and use the support of Buteyko Breathing
Read the detailed description
in this study, we will randolmly recruit 40 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will be catagorized to one of both groupsl, group I or group II (N=20 patient in the group). Both groups will receive smokinh hyeigne approach for 6 months. Group I will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days, except fridays, weekly for 6 months).
- Conditions
- Tobacco Smoking, Eustachian Tube Dysfunction
- Being tested
- Buteyko breathing plus smoking hyeigne approach, smoking hygiene appraoch
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko breathing plus smoking hyeigne approachBehavioural
in this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months.This group will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days weekly, except fridays, for 6 months).
smoking hygiene appraochBehavioural
in this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | in this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months.This group will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days weekly, except fridays, for 6 months). Receives: Behavioral: Buteyko breathing plus smoking hyeigne approach |
| group number 2 | Active comparator | in this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months. Receives: Behavioral: smoking hygiene appraoch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eustachian Tube dyafucntion questionaire
it is a questionaire contain 7 items
Measured: it will be measured after 6 months
Secondary outcomes (6)
percentage of change in type of tympanmetery
it will assess percenatge of type c tympanometry
Measured: it will be measured after 6 months
forced vital capcity
it is a pulmaonry fucntion test
Measured: it will be measured after 6 months
force expiratory volume (FEV1)
it will be mesured in the first second of expiration as a pulmaonry fucntion test
Measured: it will be measured after 6 months
FEV1/FVC
it is a pulmaonry fucntion test
Measured: it will be measured after 6 monthd
physical summary of parent form child health questinaire
it will assess quality of life
Measured: it will be measured after 6 months
mental summary of parent form child health questinaire
it will assess quality of life
Measured: it will be measured after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Sep 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236580
- Sponsor's protocol ID
- IRB00014233-50
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Efficacy of Adding Buteyko Breathing to Approach of Smoking Hygiene on Dysfucntion of Eustachian Tube and Lung Functions in Adolescnets Who Are Passively Exposed to Tobacco Smoke?
- ClinicalTrials.gov ID
- NCT07236580
- Acronym / sponsor ID
- IRB00014233-50
- Conditions
- Tobacco Smoking, Eustachian Tube Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 19 Nov 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.
adolescents are usually exposed to tobacco smoke passively. this can reduce their lung functions and negatively impact functions of Eustachian tube. The solution is to lower rates to tobacco exposure and use the support of Buteyko Breathing
Detailed description
in this study, we will randolmly recruit 40 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will be catagorized to one of both groupsl, group I or group II (N=20 patient in the group). Both groups will receive smokinh hyeigne approach for 6 months. Group I will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days, except fridays, weekly for 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: Buteyko breathing plus smoking hyeigne approachin this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months.This group will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days weekly, except fridays, for 6 months). |
| group number 2 | Active comparator | Behavioral: smoking hygiene appraochin this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Dysfucntion of Eustachian Tube (obstructive chronic form)
- adolescents with passive tobacco exposure from smoking parent or household member
- adolscent participants whose parents approve the participation
Key exclusion criteria (3 listed)
- cardiac problem
- chest disease
- renal/hepatic disease
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 |
|---|---|---|
| Buteyko breathing plus smoking hyeigne approachin this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months.This group will additionally receive Buteyko Breathing 30-minute apprach (this appraoch will be appleid by patients all days weekly, except fridays, for 6 months). | Behavioural | group number 1 |
| smoking hygiene appraochin this group, we will include 20 adolescents who are usually exposed to tobacco smoke passively in house from smoking parent or household members. these adolescents will complain chronic dysfunction of their Eustachian Tube (chronic obstructive dysfucntion) . adolescents will receive smoking hyeigne approach for 6 months. | Behavioural | group number 2 |
Primary outcome
Eustachian Tube dyafucntion questionaire
Time frame: it will be measured after 6 months
it is a questionaire contain 7 items
6 secondary outcomes
percentage of change in type of tympanmetery
Time frame: it will be measured after 6 months
forced vital capcity
Time frame: it will be measured after 6 months
force expiratory volume (FEV1)
Time frame: it will be measured after 6 months
FEV1/FVC
Time frame: it will be measured after 6 monthd
physical summary of parent form child health questinaire
Time frame: it will be measured after 6 months
mental summary of parent form child health questinaire
Time frame: it will be measured after 6 months
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 19 Nov 2025.
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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.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko breathing plus smoking hyeigne approach and smoking hygiene appraoch in people with Tobacco Smoking and Eustachian Tube Dysfunction, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 19 Nov 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 Egypt. 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 Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eustachian Tube dyafucntion questionaire (time frame: it will be measured after 6 months). 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 19 Nov 2025.