Sudden Sensorineural Hearing LossNCT05608161
Speech Perception Impairment Follow Complete Recovery of Sudden Sensorineural Hearing Loss
An observational study of Sudden Sensorineural Hearing Loss, run by Peking University People's Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- speech in noise test
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with unilateral sudden sensorineural hearing loss who was treated in the outpatient department of our hospital.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- speech in noise test
- Keywords
- Unilateral sudden sensorineural hearing loss, information masking, energy masking, neural mechanisms
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: speech in noise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Noisy speech recognition rate at admission，6 months, 12 months and 18 months after hearing recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start10 Nov 2022 (estimated)
- Primary completion10 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Xin, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608161
- Sponsor's protocol ID
- SNH-SP-01
- Status last verified
- Nov 2022
- First submitted
- 11 May 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Peripheral Hearing Loss and Auditory Perception Impairment in Patients With Unilateral Sudden Deafness and Its Underlying Neural Mechanism
- ClinicalTrials.gov ID
- NCT05608161
- Acronym / sponsor ID
- SNH-SP-01
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- Unilateral sudden sensorineural hearing loss, information masking, energy masking, neural mechanisms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral sudden deafness with complete recovery of peripheral hearing | – | Diagnostic Test: speech in noise testThe 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. |
| Healthy control group | – | Diagnostic Test: speech in noise testAge-, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral sudden sensorineural hearing loss who was treated in the outpatient department of our hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speech in noise testThe 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. | Diagnostic test | Healthy control group, Patients with unilateral sudden deafness with complete recovery of peripheral hearing |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Sensorineural Hearing Loss, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.