NCT05608161

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

May 11, 2022

Last Update Submit

November 7, 2022

Conditions

Keywords

Unilateral sudden sensorineural hearing lossinformation maskingenergy maskingneural mechanisms

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Noisy speech recognition rate

    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

Study Arms (2)

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

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

Interventions

speech in noise testDIAGNOSTIC_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 groupPatients with unilateral sudden deafness with complete recovery of peripheral hearing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with unilateral sudden sensorineural hearing loss who was treated in the outpatient department of our hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Hearing Tests

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 11, 2022

First Posted

November 8, 2022

Study Start

November 10, 2022

Primary Completion

May 10, 2023

Study Completion

May 31, 2023

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share