- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236580
Buteyko Breathing and Approach of Smoking Hygiene: Effects on Dysfucntion of Eustachian Tube and Lung Functions
November 15, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali MA Ismail, lecturer
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: Ahmed MA Ismail, lecturer
- Phone Number: 01031321109
- Email: allooka2012@gmail.com
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Cairo University
-
Contact:
- ali ismail, lecturer
- Phone Number: 02 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- cardiac problem
- chest disease
- renal/hepatic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group number 1
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).
|
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).
|
|
Active Comparator: group number 2
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eustachian Tube dyafucntion questionaire
Time Frame: it will be measured after 6 months
|
it is a questionaire contain 7 items
|
it will be measured after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of change in type of tympanmetery
Time Frame: it will be measured after 6 months
|
it will assess percenatge of type c tympanometry
|
it will be measured after 6 months
|
|
forced vital capcity
Time Frame: it will be measured after 6 months
|
it is a pulmaonry fucntion test
|
it will be measured after 6 months
|
|
force expiratory volume (FEV1)
Time Frame: it will be measured after 6 months
|
it will be mesured in the first second of expiration as a pulmaonry fucntion test
|
it will be measured after 6 months
|
|
FEV1/FVC
Time Frame: it will be measured after 6 monthd
|
it is a pulmaonry fucntion test
|
it will be measured after 6 monthd
|
|
physical summary of parent form child health questinaire
Time Frame: it will be measured after 6 months
|
it will assess quality of life
|
it will be measured after 6 months
|
|
mental summary of parent form child health questinaire
Time Frame: it will be measured after 6 months
|
it will assess quality of life
|
it will be measured after 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, lecturer, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 15, 2026
Study Registration Dates
First Submitted
November 15, 2025
First Submitted That Met QC Criteria
November 15, 2025
First Posted (Actual)
November 19, 2025
Study Record Updates
Last Update Posted (Actual)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 15, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00014233-50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Smoking
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Johns Hopkins UniversityNational Center for Advancing Translational Sciences (NCATS); Community Partnership...CompletedSmoking Cessation | Smoking Reduction | Smoking, TobaccoUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
University of Colorado, DenverUniversity of OklahomaRecruitingSmoking Cessation | Tobacco | Quitting Smoking | Tobacco Abstinence | Smoking (Tobacco) Addiction | Smoking ( Cigarette)United States
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedTobacco Smoking | Cigarette Smoking | Smoking, TobaccoUnited States
-
University of ArizonaNational Center for Complementary and Integrative Health (NCCIH); West Virginia...CompletedSmoking Cessation | Tobacco Use | Tobacco Smoking | Smoking, Tobacco | Guided ImageryUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Completed
-
RAI Services CompanyTerminatedSmoking | TobaccoUnited States
-
RAI Services CompanyRecruitingSmoking | TobaccoUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States