Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
NCT05435612

Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation

Led by Chinese PLA General Hospital · Updated on 2023-06-07

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild hearing loss (30 dB HL). Asymmetrical hearing loss (AHL) refers to severe to profound sensorineural hearing loss in the bad ear (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) and mild to moderate hearing loss in the contralateral ear. Moderate hearing loss (30≤mean pure-tone hearing threshold≤55dBHL). It is generally acknowledged that SSD is a particular clinical manifestation of AHL. The number of people who have hearing loss accounts for 5.3% of the total population, with children for 9%. According to the Second National Sampling Survey on Disabled Persons, China has 27.8 million people with hearing disabilities. The incidence of SSD adults in the United States is 7.2%, with 60,000 new cases per year, compared with 7,500 new patients with SSD annually in the UK. The incidence of SSD in neonates is 0.04%-0.34%, and it ranges from 0.1% to 0.5% in children and adolescents. The etiology of congenital SSD is primarily unknown, which is related to genes. Among the causes of acquired SSD, sudden deafness is the most common. Other causes include head trauma, Meniere's disease, labyrinthitis, unilateral acoustic neuroma, middle ear surgery, ototoxic drug exposure, Virus infection, noise-induced deafness, senile deafness, etc. SSD and AHL impede intellectual development and speech development in children and adolescents, which is associated with the side of hearing loss. For example, children with right-sided hearing loss have relatively poor language learning, logical thinking, and divergent thinking. In contrast, children with left-sided hearing loss have weaker analytical, comprehensive and visual memory abilities and relatively poor spatial imagination and visual-motor coordination. In addition, the lack of long-term monaural listening and sound source localization makes SSD children require excessive concentration, which is prone to fatigue and behavioral problems, and their academic performance is lower than that of normal children.

CONDITIONS

Official Title

Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Age: 12 years old and above
  2. Language ability: postlingual deafness, able to cooperate with sentence test in noise
  3. Normal mental, intelligence and motor development
  4. Patients who meet the diagnosis of single-sided deafness and asymmetric hearing loss
Not Eligible

You will not qualify if you...

  1. Cochlear malformation (except large vestibular aqueduct syndrome)
  2. Retrocochlear lesions
  3. Incomplete implantation of cochlear implant electrodes
  4. Non-Chinese Mandarin communication

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100085

Actively Recruiting

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Research Team

H

Haiqiao Du, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation | DecenTrialz