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

Primary Purpose

Unilateral Deafness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cochlear implant
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Deafness

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

single-sided deafness group(SSD Group)

asymmetric hearing loss group(AHL Group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
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.
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.
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.
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.
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.

Secondary Outcome Measures

THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
QLBHE (Quality of Life for Bilateral Hearing Effect)
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
QLBHE (Quality of Life for Bilateral Hearing Effect)
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
QLBHE (Quality of Life for Bilateral Hearing Effect)
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
QLBHE (Quality of Life for Bilateral Hearing Effect)
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
QLBHE (Quality of Life for Bilateral Hearing Effect)
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.

Full Information

First Posted
June 6, 2022
Last Updated
June 5, 2023
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05435612
Brief Title
Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation
Official Title
Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-sided deafness group(SSD Group)
Arm Type
Experimental
Arm Description
The single-sided group(SSD group)consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
Arm Title
asymmetric hearing loss group(AHL Group)
Arm Type
Experimental
Arm Description
The asymmetric hearing loss group(AHL group)consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation.
Intervention Type
Device
Intervention Name(s)
cochlear implant
Intervention Description
Patients enrolled in the study undergo the cochlear implant surgery.
Primary Outcome Measure Information:
Title
speech recognition
Description
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.
Time Frame
The tests are conducted before the cochlear implantation.
Title
speech recognition
Description
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.
Time Frame
The tests are conducted 1 months after CI activation.
Title
speech recognition
Description
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.
Time Frame
The tests are conducted 3 months after CI activation.
Title
speech recognition
Description
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.
Time Frame
The tests are conducted 6 months after CI activation.
Title
speech recognition
Description
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.
Time Frame
The tests are conducted 12 months after CI activation.
Title
sound localization
Description
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Time Frame
The test is conducted before the cochlear implantation.
Title
sound localization
Description
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Time Frame
The test is conducted 1 months after CI activation.
Title
sound localization
Description
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Time Frame
The test is conducted 3 months after CI activation.
Title
sound localization
Description
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Time Frame
The test is conducted 6 months after CI activation.
Title
sound localization
Description
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Time Frame
The test is conducted 12 months after CI activation.
Title
Objective electroencephalography-based assessment(EEG)
Description
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.
Time Frame
The test is conducted before the cochlear implantation.
Title
Objective electroencephalography-based assessment(EEG)
Description
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.
Time Frame
The test is conducted 1 months after CI activation.
Title
Objective electroencephalography-based assessment(EEG)
Description
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.
Time Frame
The test is conducted 3 months after CI activation.
Title
Objective electroencephalography-based assessment(EEG)
Description
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.
Time Frame
The test is conducted 6 months after CI activation.
Title
Objective electroencephalography-based assessment(EEG)
Description
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.
Time Frame
The test is conducted 12 months after CI activation.
Secondary Outcome Measure Information:
Title
THI (Tinnitus Handicap Inventory)
Description
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Time Frame
The test is conducted before the cochlear implantation.
Title
THI (Tinnitus Handicap Inventory)
Description
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Time Frame
The test is conducted 1 months after CI activation.
Title
THI (Tinnitus Handicap Inventory)
Description
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Time Frame
The test is conducted 3 months after CI activation.
Title
THI (Tinnitus Handicap Inventory)
Description
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Time Frame
The test is conducted 6 months after CI activation.
Title
THI (Tinnitus Handicap Inventory)
Description
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Time Frame
The test is conducted 12 months after CI activation.
Title
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Description
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
Time Frame
The test is conducted before the cochlear implantation.
Title
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Description
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
Time Frame
The test is conducted 1 months after CI activation.
Title
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Description
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
Time Frame
The test is conducted 3 months after CI activation.
Title
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Description
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
Time Frame
The test is conducted 6 months after CI activation.
Title
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Description
SSQ12 questionnaire investigate the listening situation in daily environment, which is divided into three dimensions: speech perception, spatial hearing and auditory quality.
Time Frame
The test is conducted 12 months after CI activation.
Title
QLBHE (Quality of Life for Bilateral Hearing Effect)
Description
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
Time Frame
The test is conducted before the cochlear implantation.
Title
QLBHE (Quality of Life for Bilateral Hearing Effect)
Description
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
Time Frame
The test is conducted 1 months after CI activation.
Title
QLBHE (Quality of Life for Bilateral Hearing Effect)
Description
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
Time Frame
The test is conducted 3 months after CI activation.
Title
QLBHE (Quality of Life for Bilateral Hearing Effect)
Description
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
Time Frame
The test is conducted 6 months after CI activation.
Title
QLBHE (Quality of Life for Bilateral Hearing Effect)
Description
QLBHE questionnaire is to evaluate the effect of bilateral listening in daily life after the use of assisted hearing devices.
Time Frame
The test is conducted 12 months after CI activation.
Title
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Description
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Time Frame
The test is conducted before the cochlear implantation.
Title
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Description
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Time Frame
The test is conducted 1 months after CI activation.
Title
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Description
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Time Frame
The test is conducted 3 months after CI activation.
Title
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Description
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Time Frame
The test is conducted 6 months after CI activation.
Title
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Description
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Time Frame
The test is conducted 12 months after CI activation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiqiao Du, MD
Phone
+86 18548921102
Email
duhq2020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiming Yang, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100085
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HAIQIAO DU, PhD
Phone
+86-010-66935474
Email
duhq2020@163.com

12. IPD Sharing Statement

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

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