Actively Recruiting

Phase Not Applicable
Age: 16Years - 90Years
All Genders
Healthy Volunteers
ID05453019

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

Age: 16Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Post-operative Follow-up

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

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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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