Eustachian Tube DysfunctionNCT07193485
Efficacy of Buteyko Breathing in Seniors With Chronic Eustachian Tube Dysfunction
A study testing Buteyko breathing in people with Eustachian Tube Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
Eustachian tube dysfunction is distressing probelm. drugs usually are not effective. compelemtary tehrapies like Buteyko breathing may be effective Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Buteyko breathing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2025to 10 Oct 2025
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Eustachian Tube Dysfunction (chronic obstructive form)
- unilateral ear affetion
- senior patients
- chronci affection more than 3 months
Who cannot join
- obesity
- cardiac probelms repsiratory problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali mohamed, lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Dokki, Giza Governorate, 11432
ali AM Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
About this study
Eustachian tube dysfunction is distressing probelm. drugs usually are not effective. compelemtary tehrapies like Buteyko breathing may be effective
Read the detailed description
forty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group I or group II. the group enroled 20 seniors. both groups wil take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Buteyko breathing, usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko breathingOther
twenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group I and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. Also, group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks.
usual careOther
twenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group II and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | twenty seniors with Eustachian tube dysfunction (chronic obstructive form) will bein group I and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. Also, group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks. Receives: Other: Buteyko breathing |
| group number 2 | Active comparator | Twenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group II oand this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eustachian Tube Dysfunction Questionnaire
it will be used to asses symptoms of Eustachian Tube Dysfunction
Measured: it will be measured after 2 weeks
Secondary outcomes (10)
systolic blood pressure
it will be measured manually by manual sphygmomanometer
Measured: it will be measured after 2 weeks
diastolic blood pressure
it will be measured manually by manual sphygmomanometer
Measured: it will be measured after 2 weeks
respiratory rate
it will assess breath number per minute
Measured: it will be measured after 2 weeks
pulse rate
it will assess pulse number per minute from radial artery
Measured: it will be measured after 2 weeks
patient health questionnaire
it will assess depression in patients
Measured: it will be measured after 2 weeks
state trait anxiety inventory
it will assess trait anxiety in patients
Measured: it will be measured after 2 weeks
perceived stress scale
it will assess stress in patients
Measured: it will be measured after 2 weeks
short form 36 questionnaire
it will assess quality of life in patients
Measured: it will be measured after 2 weeks
profile of mood satus
it will assess mood in patients
Measured: it will be measured after 2 weeks
percenatge of tympanometry (type C)
it will assess percenatge of type c tympanometry
Measured: it will be measured after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start12 May 2025
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies 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
- NCT07193485
- Sponsor's protocol ID
- IRB00014233-36
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Sep 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buteyko Breathing in Seniors With Chronic Eustachian Tube Dysfunction
- ClinicalTrials.gov ID
- NCT07193485
- Acronym / sponsor ID
- IRB00014233-36
- Conditions
- Eustachian Tube Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 25 Sep 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.
Eustachian tube dysfunction is distressing probelm. drugs usually are not effective. compelemtary tehrapies like Buteyko breathing may be effective
Detailed description
forty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group I or group II. the group enroled 20 seniors. both groups wil take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks.
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 | Other: Buteyko breathingtwenty seniors with Eustachian tube dysfunction (chronic obstructive form) will bein group I and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. Also, group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks. |
| group number 2 | Active comparator | Other: usual careTwenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group II oand this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Eustachian Tube Dysfunction (chronic obstructive form)
- unilateral ear affetion
- senior patients
- chronci affection more than 3 months
Key exclusion criteria (2 listed)
- obesity
- cardiac probelms repsiratory problems
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 breathingtwenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group I and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. Also, group I will aslo receive 30-min Buteyko breathing two times daily for 14 weeks. | Other | group number 1 |
| usual caretwenty seniors with Eustachian tube dysfunction (chronic obstructive form) will be ranomized to group II and this group will take usual care (budesonide spray in nose in 64 microgram concentration one time per day plus the intake of a tablet two times daily containing containing 20-mg contration of pseudoephedrine hydrochloride and 5-mg concentration of loratadine) for 2 weeks. | Other | group number 2 |
Primary outcome
Eustachian Tube Dysfunction Questionnaire
Time frame: it will be measured after 2 weeks
it will be used to asses symptoms of Eustachian Tube Dysfunction
10 secondary outcomes
systolic blood pressure
Time frame: it will be measured after 2 weeks
diastolic blood pressure
Time frame: it will be measured after 2 weeks
respiratory rate
Time frame: it will be measured after 2 weeks
pulse rate
Time frame: it will be measured after 2 weeks
patient health questionnaire
Time frame: it will be measured after 2 weeks
state trait anxiety inventory
Time frame: it will be measured after 2 weeks
perceived stress scale
Time frame: it will be measured after 2 weeks
short form 36 questionnaire
Time frame: it will be measured after 2 weeks
profile of mood satus
Time frame: it will be measured after 2 weeks
percenatge of tympanometry (type C)
Time frame: it will be measured after 2 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 25 Sep 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 mohamed, lecturer contact
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 in people with 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 4 inclusion and 2 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 25 Sep 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 Dysfunction Questionnaire (time frame: it will be measured after 2 weeks). 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 25 Sep 2025.