Actively Recruiting
Effects of Cochlear Implantation on Tinnitus and Its Symptoms
Led by Chinese PLA General Hospital · Updated on 2023-06-06
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating tinnitus, a condition caused by abnormal activity in the central auditory system, in patients who have received cochlear implants. The study focuses on how electrical stimulation from the cochlear implant affects tinnitus symptoms and aims to understand the underlying mechanisms using a new clinical electroencephalogram (EEG) technique. This EEG method helps locate tinnitus origins and analyze how electrical stimulation suppresses tinnitus, especially since these patients cannot undergo MRI due to implant magnets. The study involves patients who received cochlear implants from various manufacturers and includes two groups: those with tinnitus and those without tinnitus before surgery. Researchers will observe changes in tinnitus loudness, frequency, and characteristics over time after electrical stimulation. The study also explores optimal electrical stimulation settings to mask tinnitus and conducts long-term EEG assessments to trace brain activity changes related to tinnitus inhibition at multiple time points up to and beyond 13 months post-implantation. Participants will undergo multiple evaluations including tinnitus questionnaires, EEG assessments, hearing tests, and anxiety scales before surgery and at scheduled follow-ups after implantation. These assessments occur at 1 week, 1 month, 2 months, 3 months, 4 months, 7 months, 13 months, and beyond 13 months. Researchers will monitor speech perception and electrical stimulation parameters, aiming to better understand and optimize tinnitus treatment through cochlear implants while tracking safety and effectiveness over time.
CONDITIONS
Brief Title
Effects of CI on Tinnitus and Its Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who received cochlear implants at the Auditory Implant Center of the Otorhinolaryngology-Head and Neck Surgery, China PLA General Hospital
- Patients aged between 16 and 90 years
- Patients with hearing loss who either had tinnitus for more than 0.25 years or no tinnitus before cochlear implant surgery
- Patients implanted with cochlear implants from MED-EL, Cochlear, Advanced Bionics, or Nurotron
- Patients who voluntarily agree to participate in the study
You will not qualify if you...
- Patients with tinnitus caused by non-ear related conditions such as hypertension, heart disease, hyperthyroidism, neurasthenia, or high cholesterol
- Patients with contraindications to cochlear implant surgery as per Chinese Medical Association guidelines
- Patients with intellectual disabilities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo cochlear implant surgery where a device is implanted behind the ear and into the cochlea.
1 visit (in-person)
Duration - Over 13 months
Participants are observed over time to assess changes in tinnitus symptoms and hearing, including electrical stimulation effects and EEG assessments.
Multiple visits at 1 week, 1 month, 2 months, 3 months, 4 months, 7 months, 13 months, and over 13 months after surgery
Trial Site Locations
Total: 1 location
1
Qian Wang
Beijing, France, China, 100085
Actively Recruiting
Research Team
Q
QIAN WANG, M.S.
S
Shi m Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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