- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05608161
Speech Perception Impairment Follow Complete Recovery of Sudden Sensorineural Hearing Loss
November 7, 2022 updated by: Ma Xin, Peking University People's Hospital
Correlation Between Peripheral Hearing Loss and Auditory Perception Impairment in Patients With Unilateral Sudden Deafness and Its Underlying Neural Mechanism
At present, few research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing.This project evaluate the speech perception function in noise of unilateral sudden hearing loss patients with with complete and partial hearing recovery by cognitive behavioral experiments, event-related potentials (ERPs) and functional magnetic resonance imaging (fMRI), and longitudinal follow-up to explore its underlying neural mechanisms.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In clinical practice, many unilateral sudden hearing loss patients with complete and partial recovery of peripheral hearing still complain of hearing discomfort, especially difficulty in speech recognition in noisy environments.
At present, there is still a lack of research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing.
From the perspective of cognitive psychology, this project uses cognitive behavioral experiments, event-related potentials (ERPs) and functional magnetic resonance imaging (fMRI) to evaluate the reverberation environment of unilateral sudden hearing loss patients with complete and partial hearing recovery, and longitudinal follow-up to explore its underlying neural mechanisms.
The investigators hope to understand the possible difficulties of binaural processing and auditory perception in patients with unilateral sudden deafness, and to explore the changes of central and cortical functions.
This study not only has important guiding significance for the treatment and rehabilitation of patients with unilateral sudden deafness, but also expands the research group on auditory perception function and the psychological and neural mechanisms involved in binaural processing, which has important theoretical significance.
Study Type
Observational
Enrollment (Anticipated)
10
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with unilateral sudden sensorineural hearing loss who was treated in the outpatient department of our hospital.
Description
Inclusion Criteria:
- 18-65 years old;
- patients with unilateral idiopathic sudden sensorineural hearing loss (at least three adjacent frequencies of hearing loss ≥ 30 dB );
- the first onset;
- Contralateral hearing is normal; 5) Hearing is cured after treatment
Exclusion Criteria:
- Sudden deafness with possible definite etiology, such as Meniere's disease, large vestibular aqueduct syndrome, trauma, retrocochlear tumor, etc.;
- Severe underlying diseases, heart disease, blood disease, pregnancy, breastfeeding, etc.;
- Suffering from other central diseases that may affect speech perception disorders, such as Alzheimer's disease, etc.;
- Those who cannot cooperate with the whole study inspection;
- Those who do not agree to be enrolled or refuse to sign the informed consent form;
- Those who are using may affect the Medications or treatments for speech perception disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with unilateral sudden deafness with complete recovery of peripheral hearing
The patients who recovered from sudden deafness underwent speech recognition rate tests under different masking conditions and different signal-to-noise ratio conditions within 2 weeks after complete recovery of peripheral hearing and were followed up 3 times at 1, 6, and 12 months after recovery.
The test content is the same as the first time.
|
The noise masker was a stream of steady-state speech-spectrum noise, whose spectrum was representative of the average spectrum of target sentences.
The speech masker was a 47-s loop of digitally combined continuous recordings for Chinese nonsense sentences.
Patients from the idiopathic sudden sensorineural hearing loss (ISSNHL) group and control group were tested bilateral (left, right) speech-in-noise (SIN) perception of various signal-to-noise ratios (SNRs) under speech and noise masking conditions.
Each participant has to complete four consequent levels of SNRs (-12, -8, -4, 0 decibel (dB) for most of control group, -8, -4, 0, 4 dB for ISSNHL group).
In addition, the benefits of spatial separation cues under these two types of masking were analyzed.
|
|
Healthy control group
Age-, gender-, and educational-matched healthy controls were enrolled as healthy control group to test speech recognition rates under different masking conditions and different signal-to-noise ratio conditions.
|
The noise masker was a stream of steady-state speech-spectrum noise, whose spectrum was representative of the average spectrum of target sentences.
The speech masker was a 47-s loop of digitally combined continuous recordings for Chinese nonsense sentences.
Patients from the idiopathic sudden sensorineural hearing loss (ISSNHL) group and control group were tested bilateral (left, right) speech-in-noise (SIN) perception of various signal-to-noise ratios (SNRs) under speech and noise masking conditions.
Each participant has to complete four consequent levels of SNRs (-12, -8, -4, 0 decibel (dB) for most of control group, -8, -4, 0, 4 dB for ISSNHL group).
In addition, the benefits of spatial separation cues under these two types of masking were analyzed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Noisy speech recognition rate
Time Frame: Change from Baseline Noisy speech recognition rate at admission,6 months, 12 months and 18 months after hearing recovery
|
The proportion of subjects correctly identifying the target sentence under different masking conditions and different signal-to-noise ratio conditions.
|
Change from Baseline Noisy speech recognition rate at admission,6 months, 12 months and 18 months after hearing recovery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 10, 2022
Primary Completion (Anticipated)
May 10, 2023
Study Completion (Anticipated)
May 31, 2023
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNH-SP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sudden Sensorineural Hearing Loss
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Auris Medical, Inc.TerminatedHearing Loss, Idiopathic Sudden SensorineuralUnited States, Korea, Republic of, Canada
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Smarty EarsNational Institutes of Health (NIH); National Institute on Deafness and Other... and other collaboratorsCompletedSpeech PerceptionUnited States
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