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

NCT ID: NCT05435612

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed 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.

Conditions

Unilateral Deafness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-sided deafness group（SSD Group）

The single-sided group（SSD group）consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation.

Group Type: EXPERIMENTAL

cochlear implant

Intervention Type: DEVICE

Patients enrolled in the study undergo the cochlear implant surgery.

asymmetric hearing loss group（AHL Group）

The asymmetric hearing loss group（AHL group）consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation.

Group Type: EXPERIMENTAL

cochlear implant

Intervention Type: DEVICE

Patients enrolled in the study undergo the cochlear implant surgery.

Interventions

cochlear implant

Patients enrolled in the study undergo the cochlear implant surgery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Cochlear malformation (except large vestibular aqueduct syndrome)

2. Retrocochlear lesions

3. Incomplete implantation of cochlear implant electrodes

4. Non-Chinese Mandarin communication

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

YangShiming

College of Otolaryngology Head and Neck Surgery, Chinese PLA General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiming Yang, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiqiao Du, MD

Role: CONTACT

duhq2020@163.com

+86 18548921102

Facility Contacts

HAIQIAO DU, PhD

Role: primary

duhq2020@163.com

+86-010-66935474

Other Identifiers

SSD-2022-01

Identifier Type: -

Identifier Source: org_study_id