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

C

Chinese PLA General Hospital (301 Hospital)

Status

Enrolling

Conditions

Unilateral Deafness

Treatments

Device: cochlear implant

Study type

Interventional

Funder types

Other

Identifiers

NCT05435612
SSD-2022-01

Details and patient eligibility

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.

Full description

Current options for hearing interventions for patients with SSD are air conduction hearing aids, bone conduction hearing aids and cochlear implants. Attributed to the United States Food and Drug Administration (FDA) approval of one manufacturer's CI for patients aged five years and older with SSD in 2019, CI has been considered by the growing population. However, few studies on CI in patients with SSD, especially in China. Therefore, the study aims to evaluate the efficacy of CI in SSD patients.

Enrollment

30 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 12 years old and above
  • Language ability: postlingual deafness, able to cooperate with sentence test in noise
  • Normal mental, intelligence and motor development
  • Patients who meet the diagnosis of single-sided deafness and asymmetric hearing loss

Exclusion criteria

  • Cochlear malformation (except large vestibular aqueduct syndrome)
  • Retrocochlear lesions
  • Incomplete implantation of cochlear implant electrodes
  • Non-Chinese Mandarin communication

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

single-sided deafness group(SSD Group)
Experimental group
Description:
The single-sided group(SSD group)consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
Treatment:
Device: cochlear implant
asymmetric hearing loss group(AHL Group)
Experimental group
Description:
The asymmetric hearing loss group(AHL group)consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
Treatment:
Device: cochlear implant

Trial contacts and locations

1

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Central trial contact

Haiqiao Du, MD

Data sourced from clinicaltrials.gov

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