Unilateral DeafnessNCT05435612
Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation
A study testing cochlear implant in people with Unilateral Deafness, run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Unilateral Deafness
- What is being tested?
- cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cochlear malformation (except large vestibular aqueduct syndrome)
- Retrocochlear lesions
- Incomplete implantation of cochlear implant electrodes
- Non-Chinese Mandarin communication
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100085
HAIQIAO DU, PhD, +86-010-66935474, duhq2020@163.com
About this study
Official title: Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation
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.
Read the 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
- Being tested
- cochlear implant
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
Patients enrolled in the study undergo the cochlear implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| single-sided deafness group（SSD Group） | Experimental | The single-sided group（SSD group）consists of 20 SSD patients voluntarily enrolled in the study and plan to undergo cochlear implantation. Receives: Device: cochlear implant |
| asymmetric hearing loss group（AHL Group） | Experimental | The asymmetric hearing loss group（AHL group）consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation. Receives: Device: cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The test is conducted 12 months after CI activation.
Secondary outcomes (20)
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Measured: The test is conducted before the cochlear implantation.
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Measured: The test is conducted 1 months after CI activation.
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Measured: The test is conducted 3 months after CI activation.
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Measured: The test is conducted 6 months after CI activation.
THI (Tinnitus Handicap Inventory)
The tinnitus-related questionnaire has a comprehensive understanding of tinnitus from three aspects(functional scale, emotional scale and catastrophic scale).
Measured: The test is conducted 12 months after CI activation.
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.
Measured: The test is conducted before the cochlear implantation.
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.
Measured: The test is conducted 1 months after CI activation.
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.
Measured: The test is conducted 3 months after CI activation.
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.
Measured: The test is conducted 6 months after CI activation.
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.
Measured: The test is conducted 12 months after CI activation.
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.
Measured: The test is conducted before the cochlear implantation.
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.
Measured: The test is conducted 1 months after CI activation.
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.
Measured: The test is conducted 3 months after CI activation.
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.
Measured: The test is conducted 6 months after CI activation.
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.
Measured: The test is conducted 12 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Measured: The test is conducted before the cochlear implantation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Measured: The test is conducted 1 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Measured: The test is conducted 3 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Measured: The test is conducted 6 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
The questionnaire evaluates the quality of life of patients from three dimensions: physiological function, psychological function and social function.
Measured: The test is conducted 12 months after CI activation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start5 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YangShiming, Chinese PLA General Hospital
- Investigators
- Shiming Yang, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435612
- Sponsor's protocol ID
- SSD-2022-01
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05435612
- Acronym / sponsor ID
- SSD-2022-01
- Conditions
- Unilateral Deafness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-sided deafness group（SSD Group） | Experimental | Device: cochlear implantThe 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） | Experimental | Device: cochlear implantThe asymmetric hearing loss group（AHL group）consists of 10 AHL patients voluntarily enrolled in the study and plan to undergo cochlear implantation. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Cochlear malformation (except large vestibular aqueduct syndrome)
- Retrocochlear lesions
- Incomplete implantation of cochlear implant electrodes
- Non-Chinese Mandarin communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cochlear implantPatients enrolled in the study undergo the cochlear implant surgery. | Device | asymmetric hearing loss group（AHL Group）, single-sided deafness group（SSD Group） |
Primary outcome
speech recognition
Time frame: The tests are conducted before the cochlear implantation.
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
Time frame: The tests are conducted 1 months after CI activation.
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
Time frame: The tests are conducted 3 months after CI activation.
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
Time frame: The tests are conducted 6 months after CI activation.
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
Time frame: The tests are conducted 12 months after CI activation.
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
Time frame: The test is conducted before the cochlear implantation.
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
Time frame: The test is conducted 1 months after CI activation.
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
Time frame: The test is conducted 3 months after CI activation.
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
Time frame: The test is conducted 6 months after CI activation.
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
sound localization
Time frame: The test is conducted 12 months after CI activation.
180° (horizonal) sound localization test is conducted to assess the sound source localization ability (pre-/post-operation).
Objective electroencephalography-based assessment(EEG)
Time frame: The test is conducted before the cochlear implantation.
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)
Time frame: The test is conducted 1 months after CI activation.
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)
Time frame: The test is conducted 3 months after CI activation.
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)
Time frame: The test is conducted 6 months after CI activation.
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)
Time frame: The test is conducted 12 months after CI activation.
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.
20 secondary outcomes
THI (Tinnitus Handicap Inventory)
Time frame: The test is conducted before the cochlear implantation.
THI (Tinnitus Handicap Inventory)
Time frame: The test is conducted 1 months after CI activation.
THI (Tinnitus Handicap Inventory)
Time frame: The test is conducted 3 months after CI activation.
THI (Tinnitus Handicap Inventory)
Time frame: The test is conducted 6 months after CI activation.
THI (Tinnitus Handicap Inventory)
Time frame: The test is conducted 12 months after CI activation.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: The test is conducted before the cochlear implantation.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: The test is conducted 1 months after CI activation.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: The test is conducted 3 months after CI activation.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: The test is conducted 6 months after CI activation.
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: The test is conducted 12 months after CI activation.
QLBHE (Quality of Life for Bilateral Hearing Effect)
Time frame: The test is conducted before the cochlear implantation.
QLBHE (Quality of Life for Bilateral Hearing Effect)
Time frame: The test is conducted 1 months after CI activation.
QLBHE (Quality of Life for Bilateral Hearing Effect)
Time frame: The test is conducted 3 months after CI activation.
QLBHE (Quality of Life for Bilateral Hearing Effect)
Time frame: The test is conducted 6 months after CI activation.
QLBHE (Quality of Life for Bilateral Hearing Effect)
Time frame: The test is conducted 12 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time frame: The test is conducted before the cochlear implantation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time frame: The test is conducted 1 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time frame: The test is conducted 3 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time frame: The test is conducted 6 months after CI activation.
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time frame: The test is conducted 12 months after CI activation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiming Yang, MD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cochlear implant in people with Unilateral Deafness, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiqiao Du, MD (+86 18548921102, duhq2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
speech recognition (time frame: The tests are conducted before the cochlear implantation.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.