NCT07193485

Brief Summary

Eustachian tube dysfunction is distressing probelm. drugs usually are not effective. compelemtary tehrapies like Buteyko breathing may be effective

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 18, 2025

Last Update Submit

September 18, 2025

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Eustachian Tube Dysfunction Questionnaire

    it will be used to asses symptoms of Eustachian Tube Dysfunction

    it will be measured after 2 weeks

Secondary Outcomes (10)

  • systolic blood pressure

    it will be measured after 2 weeks

  • diastolic blood pressure

    it will be measured after 2 weeks

  • respiratory rate

    it will be measured after 2 weeks

  • pulse rate

    it will be measured after 2 weeks

  • patient health questionnaire

    it will be measured after 2 weeks

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: usual care

Interventions

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.

group number 1
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.

group number 2

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Eustachian Tube Dysfunction (chronic obstructive form)
  • unilateral ear affetion
  • senior patients
  • chronci affection more than 3 months

You may not qualify if:

  • obesity
  • cardiac probelms repsiratory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

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

Ali mohamed, lecturer

CONTACT

allooka2012@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

September 18, 2025

First Posted

September 25, 2025

Study Start

May 12, 2025

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

EG(1)