Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease

Completed

• Conditions: Behcet's Disease With Multisystem Involvement

• Registration Number: NCT05999461
• Lead Sponsor: Assiut University

Brief Summary

Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular abnormalities as well as cochlear function affection have been found. The inflammatory process in BD may be the cause of audiometry abnormalities in those patients. The aim of this study is to assess hearing dysfunction in Behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and acoustic reflex

Detailed Description

pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is plotted on an audiogram, which displays intensity as a function of frequency.

Speech audiometry employs speech signals to assess if the patient has problems hearing speech or speech in noise. Speech audiometry can be used to examine the processing ability and if it is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or auditory centers of the cortex.

Tympanogram is a test of middle ear functioning. This objective test also allows to view the functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss from a sensorineural hearing loss.

Optical coherence tomography angiography (OCT-A) for imaging the microvasculature of the retina and the choroid.

Behcet disease current activity form for assessment of disease activity range from 0 to 12 . 12 represents the highest disease activity. It depends on the symptoms present over the last 4 weeks.

Study Timeline

• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-12
• Study First Posted: 2023-08-21
• Study Start: 2024-01-31
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All patients fulfill the International Criteria of behcet disease

Exclusion Criteria

• age more than 50
• ear infection,
• ear trauma, acoustic trauma, or usage of ototoxic drugs.
• Also, associated systemic diseases that can affect the hearing as infectious diseases (e.g., mumps, CMV), granulomatous diseases (e.g., sarcoidosis, Wegner's granulomatosis), other autoimmune diseases (e.g., Rheumatoid arthritis, Cogan's syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone (e.g., Paget's disease).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation of hearing abnormalities with retinal ischemia	3 months	oct angiography
Detection of hearing abnormalities in behcet disease	3 MONTHS	pure tone audiometry, tympanogram and acoustic reflex

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt