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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05608161
Other study ID # SNH-SP-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 10, 2022
Est. completion date May 31, 2023

Study information

Verified date November 2022
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date May 31, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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