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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: speech in noise test
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.
Diagnostic test: speech in noise test
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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