search
Back to results

Effects of CI on Tinnitus and Its Symptoms

Primary Purpose

Tinnitus

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 Tinnitus focused on measuring tinnitus, electrical stimulation, cochlear implant

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. This study included patients who received cochlear implants at the Auditory Implant Center of the Otorhinolaryngology-Head and Neck Surgery, China PLA General Hospital;
  • 2. The patients ranged from 16 to 90 years old;
  • 3. The patient experienced hearing loss and had either tinnitus longer than 0.25 years (experimental group 1) or no tinnitus (control group 2) before the cochlear implant surgery;
  • 4. The cochlear implants accepted by patients included products from MED-EL, Cochlear, Advanced Bionics and Nurotron;
  • 5. All patients voluntarily participated in the study.

Exclusion Criteria:

  • 1 Tinnitus types exclude non otogenic tinnitus (including tinnitus caused by hypertension, heart disease, hyperthyroidism, neurasthenia, hyperlipidemia, etc.);
  • 2 Contraindications of cochlear implant surgery (refer to the guidelines for cochlear implant 2013 of the Chinese Medical Association);
  • 3 Intellectual deficiency

Sites / Locations

  • Qian WangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tinnitus group

without tinnitus group

Arm Description

Patients who have tinnitus got cochlear implant

Patients who have no tinnitus got cochlear implant

Outcomes

Primary Outcome Measures

Electrical stimulation channel number
Stimulating basement membrane with cochlear implant electrode to match tinnitus frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus characteristic information questionnaire
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Tinnitus loudness(CI electrical stimulation intensity)
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
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)
The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded.
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.
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.
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage

Secondary Outcome Measures

Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Self-Rating Anxiety Scale (SAS) questionnaire
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.

Full Information

First Posted
June 22, 2022
Last Updated
June 5, 2023
Sponsor
Chinese PLA General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05453019
Brief Title
Effects of CI on Tinnitus and Its Symptoms
Official Title
Effects of Cochlear Implantation on Tinnitus and Its Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (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
Abnormal activity in the central auditory system is the cause of subjective experience of tinnitus. Electrical stimulation can inhibit the abnormal activity of auditory related neurons in patients with tinnitus. In recent years, the application of electrical stimulation in the treatment of tinnitus is a hot research topic, and has made some progress. However, its treatment is still in the discussion stage, and there is no best scheme suitable for clinical practice. At present, scholars have found that cochlear electrode stimulation can inhibit tinnitus, but its mechanism is not clear. It is difficult to locate the origin of tinnitus, and the location of electrode stimulation and stimulation parameters still need to be further optimized. Because the implanted part of the cochlear implant contains magnets, the patients cannot perform functional MRI. However, the prevalence of tinnitus in this group is very high (67.0~100.0%, with an average of 80.0%), so it is of great value and significance to study the effect of tinnitus treatment in such patients. In this study, a new clinical electroencephalogram (EEG) technique was used to make up for the lack of MRI imaging in patients with electrode implantation. EEG analyzes the functional connection of different brain regions through EEG test electrodes, uses the traceability function of EEG software to locate the location of tinnitus, analyzes the process of tinnitus inhibition by electrical stimulation, and explains the mechanism of tinnitus inhibition by electrical stimulation from a new perspective.
Detailed Description
Research content 1.1 Study on the change law of tinnitus affected by electrical stimulation after electrode implantation: 1) The change of tinnitus before operation after cochlear implantation; 2) Long term observation of electrical stimulation after cochlear implantation: (1) The change rule of tinnitus loudness after electrical stimulation (how long can it recover to be stable after power on); (2) The regularity of tinnitus frequency after electrical stimulation; (3) The recovery of tinnitus after electrode implantation for various causes of deafness. 1.2 Study on the mechanism of electric stimulation inhibiting tinnitus: 1) Changes of resting EEG in patients with tinnitus before surgery, before surgery-after surgery, 1 month, 2 months, 3 months, 6 months, 12 month, more than 12 months; 2) The compilation of resting electroencephalogram analysis program; 3) The resting brain wave shape was analyzed to trace the anatomical position of the artificial cochlea to inhibit tinnitus. 1.3 Study on the optimal setting of electrode stimulation for tinnitus treatment: 1) Setting different electric stimulation frequency and stimulation rate parameters to mask tinnitus; 2) Set the procedure of electric stimulation cochlear implant to mask tinnitus. Research objectives 1) Summarize the changes of tinnitus after electrode implantation (effective treatment time, diseases suitable for electrical stimulation treatment, etc.); 2) Infer the mechanism of electric stimulation inhibiting tinnitus; 3) Set electrical stimulation parameters to effectively suppress tinnitus. Scientific problems to be solved Our study group plan to use more advanced EEG technology to explore the principle of electric stimulation to suppress tinnitus, find out the effective scheme of electric stimulation to treat tinnitus, and help more patients solve the problem of tinnitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, electrical stimulation, cochlear implant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
tinnitus group
Arm Type
Experimental
Arm Description
Patients who have tinnitus got cochlear implant
Arm Title
without tinnitus group
Arm Type
Active Comparator
Arm Description
Patients who have no tinnitus got cochlear implant
Intervention Type
Device
Intervention Name(s)
Cochlear Implant
Intervention Description
The surgeon will make a small cut (incision) behind patient's ear, and form a small hole in the portion of skull bone (mastoid) where the internal device rests. Then the surgeon create a small opening in the cochlea in order to thread the electrode of the internal cochlear implant device. The skin incision is stitched closed so that the internal device is under the skin.
Primary Outcome Measure Information:
Title
Electrical stimulation channel number
Description
Stimulating basement membrane with cochlear implant electrode to match tinnitus frequency. The cochlear implant electrode number is recorded.
Time Frame
1 week after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
1 month after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
2 months after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
3 months after CI operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
4 months after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
7 months after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
13 months after operation
Title
Electrical stimulation channel number
Description
frequency. The cochlear implant electrode number is recorded.
Time Frame
over 13 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
Pre-operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
1 week after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
1 month after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
2 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
3 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
4 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
7 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
13 months after operation
Title
Tinnitus characteristic information questionnaire
Description
A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis.
Time Frame
over 13 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
1 week after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
1 month after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
2 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
3 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
4 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
7 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
13 months after operation
Title
Tinnitus loudness(CI electrical stimulation intensity)
Description
The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp).
Time Frame
over 13 months after operation
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
Pre-operation
Title
Objective electroencephalography-based assessment(EEG)
Description
The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded.
Time Frame
1 week after operation
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
1 month after operation
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
2 months after operation
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
3 months after operation
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
4 months after operation
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
7 months after operation
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
13 months after operation
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
over 13 months after operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
Pre-operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
1 months after operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
2 month after operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
4 months after operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
7 months after operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
13 months after CI operation
Title
Speech perception
Description
The patient are tested for speech recognition and the results were recorded as a percentage
Time Frame
over 13 months after CI activation
Secondary Outcome Measure Information:
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
pre-operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
1 month after operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
2 months after operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
4 months after operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
7 month after operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
13 month after operation
Title
Pure tone test
Description
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Time Frame
over 13 month after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
Pre-operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
1 month after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
2 months after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
4 months after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
7 months after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
13 months after operation
Title
Self-Rating Anxiety Scale (SAS) questionnaire
Description
Assessment of patients' mental state (depression, anxiety, insomnia),The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points.
Time Frame
over 13 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. This study included patients who received cochlear implants at the Auditory Implant Center of the Otorhinolaryngology-Head and Neck Surgery, China PLA General Hospital; 2. The patients ranged from 16 to 90 years old; 3. The patient experienced hearing loss and had either tinnitus longer than 0.25 years (experimental group 1) or no tinnitus (control group 2) before the cochlear implant surgery; 4. The cochlear implants accepted by patients included products from MED-EL, Cochlear, Advanced Bionics and Nurotron; 5. All patients voluntarily participated in the study. Exclusion Criteria: 1 Tinnitus types exclude non otogenic tinnitus (including tinnitus caused by hypertension, heart disease, hyperthyroidism, neurasthenia, hyperlipidemia, etc.); 2 Contraindications of cochlear implant surgery (refer to the guidelines for cochlear implant 2013 of the Chinese Medical Association); 3 Intellectual deficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
QIAN WANG, M.S.
Phone
+8618211068103
Email
only_elizabeth@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shi m Yang
Phone
01068159050
Email
yangsm301@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi m Yang, M.D., Ph.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Qian Wang
City
Beijing
State/Province
France
ZIP/Postal Code
100085
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QIAN WANG
Phone
+8618211068103
Email
only_elizabeth@126.com

12. IPD Sharing Statement

Learn more about this trial

Effects of CI on Tinnitus and Its Symptoms

We'll reach out to this number within 24 hrs