Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedStudy Start
First participant enrolled
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJune 7, 2023
June 1, 2023
3 years
June 6, 2022
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (15)
speech recognition
Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.
The tests are conducted before the cochlear implantation.
speech recognition
Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.
The tests are conducted 1 months after CI activation.
speech recognition
Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.
The tests are conducted 3 months after CI activation.
speech recognition
Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.
The tests are conducted 6 months after CI activation.
speech recognition
Both speech recognition score and speech recognition threshold are conducted to assess the auditory sensitivity and articulation of the spoken language. That is to evaluate the subjects' ability to recognize and understand speech in actual communication.
The tests are conducted 12 months after CI activation.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
The test is conducted before the cochlear implantation.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
The test is conducted 1 months after CI activation.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
The test is conducted 3 months after CI activation.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
The test is conducted 6 months after CI activation.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
The test is conducted 12 months after CI activation.
Objective electroencephalography-based assessment(EEG)
EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.
The test is conducted before the cochlear implantation.
Objective electroencephalography-based assessment(EEG)
EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.
The test is conducted 1 months after CI activation.
Objective electroencephalography-based assessment(EEG)
EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.
The test is conducted 3 months after CI activation.
Objective electroencephalography-based assessment(EEG)
EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.
The test is conducted 6 months after CI activation.
Objective electroencephalography-based assessment(EEG)
EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis.
The test is conducted 12 months after CI activation.
Secondary Outcomes (20)
THI (Tinnitus Handicap Inventory)
The test is conducted before the cochlear implantation.
THI (Tinnitus Handicap Inventory)
The test is conducted 1 months after CI activation.
THI (Tinnitus Handicap Inventory)
The test is conducted 3 months after CI activation.
THI (Tinnitus Handicap Inventory)
The test is conducted 6 months after CI activation.
THI (Tinnitus Handicap Inventory)
The test is conducted 12 months after CI activation.
- +15 more secondary outcomes
Study Arms (2)
single-sided deafness group（SSD Group）
EXPERIMENTALThe single-sided group（SSD group）consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
asymmetric hearing loss group（AHL Group）
EXPERIMENTALThe asymmetric hearing loss group（AHL group）consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
Interventions
Patients enrolled in the study undergo the cochlear implant surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cochlear malformation (except large vestibular aqueduct syndrome)
- Retrocochlear lesions
- Incomplete implantation of cochlear implant electrodes
- Non-Chinese Mandarin communication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100085, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shiming Yang, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- College of Otolaryngology Head and Neck Surgery, Chinese PLA General Hospital
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 28, 2022
Study Start
July 5, 2022
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
June 7, 2023
Record last verified: 2023-06