NCT07236580

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Tobacco SmokingEustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Eustachian Tube dyafucntion questionaire

    it is a questionaire contain 7 items

    it will be measured after 6 months

Secondary Outcomes (6)

  • percentage of change in type of tympanmetery

    it will be measured after 6 months

  • forced vital capcity

    it will be measured after 6 months

  • force expiratory volume (FEV1)

    it will be measured after 6 months

  • FEV1/FVC

    it will be measured after 6 monthd

  • physical summary of parent form child health questinaire

    it will be measured after 6 months

  • +1 more secondary outcomes

Study Arms (2)

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).

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.

Behavioral: smoking hygiene appraoch

Interventions

Buteyko breathing plus smoking hyeigne approachBEHAVIORAL

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).

group number 1
smoking hygiene appraochBEHAVIORAL

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.

group number 2

Eligibility Criteria

Age13 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • cardiac problem
  • chest disease
  • renal/hepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ahmed MA Ismail, lecturer

CONTACT

01031321109allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

EG(1)