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NCT Number: NCT07431125

Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazhar university Hopital in Assiut

Asyut, Asyut Governorate, 17511, Egypt

Location status: Recruiting

Location contact

tarek mansour, head of research committe

CONTACT

[email protected]

0201006237731

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane
  • Average Airborne Gap Above 20 decibels Exclusion Criteria
  • Sensorineural hearing loss
  • Chronic otitis media
  • TM perforation
  • Previous ear surgery

Treatment and study plan

Exporlation Tympanotomy

Procedure

exploration tympanotomy of the middle ear and ossicles to diagnose or detect actual causes of conductive hearing loss and correct it according to the cause

Primary outcomes

  1. Improvement of the Airborne ( conductive ) gap

    Time frame: up to three months Surgery

    Difference between preoperative and postoperative Average Airbone gap in dicebel

Study contacts

Contact information is provided by the study sponsor or research team.

tarek Mansour, head of research committe

CONTACT

[email protected]

+0201006237731

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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