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Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss

Primary Purpose

Sudden Sensorineural Hearing Loss

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Coenzyme I for Injection + conventional treatment
Conventional treatment
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Sensorineural Hearing Loss focused on measuring Sudden Sensorineural Hearing Loss, Coenzyme I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18yrs.the 2019 American Sudden Deafness Guidelines are for patients with sudden deafness over 18 years of age; Patients diagnosed with sudden deafness, i.e. unexplained sensorineural hearing loss occurring within 72 hours, with hearing threshold ≥30 in at least 3 consecutive frequencies, refer to the 2019 American Sudden Deafness Guidelines; Unilateral sudden deafness; Within 1 week of the onset of sudden deafness, no treatment in another hospital/our hospital; No major neurological disease, serious systemic disease, family genetic history, major mental illness; Informed and agreed to join the experiment, no plan to move out or go out within 1 month. Exclusion Criteria: Other diseases such as acoustic neuroma diagnosed by imaging; Those who cannot tolerate NAD+; pregnant； Any other circumstances that the investigator believes should be excluded from this study； Do not agree to join the experiment, plan to move out or go out within 1 month.

Sites / Locations

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd.

Procedure: conventional treatment.

Outcomes

Primary Outcome Measures

Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Pure Tone Average(PTA)
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.

Secondary Outcome Measures

Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.

Full Information

First Posted
February 16, 2023
Last Updated
May 8, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05849519
Brief Title
Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
Official Title
Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
February 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sudden sensorineural hearing loss is one of the most common emergencies in otorhinolaryngology, and its incidence is increasing year by year and tends to be younger. At present, the pathogenesis of sudden deafness is not clear and the individual treatment effects vary significantly. In order to break through this specific treatment bottleneck, this project pioneered the clinical application of the co-regulator nicotinamide adenine dinucleotide (NAD+) in the treatment of sudden deafness. Therefore, this project intends to use pure tone audiometry, speech audiometry, tinnitus disability scale THI, tinnitus subjective visual analog score method VAS, ear fullness subjective visual analog score method VAS for data analysis, and explore the safety of coenzyme I for injection on sudden deafness and efficacy assessment.
Detailed Description
The recruited participants were patients with sudden hearing deafness, and the basic demographic data, including name, gender, age, medical history, etc., were collected. According to the inclusion and exclusion criteria, the patients were randomly divided into the experimental group and the control group. The experimental group was given conventional treatment + coenzyme I for injection, and the control group was given conventional treatment for 14 days. Baseline data were collected before treatment, and post-treatment data were collected on 3d, 7d, 14d，1m and 3m of treatment. Baseline data and post-treatment data included pure tone audiometry, speech audiometry, tinnitus THI scale, tinnitus VAS scale, tinnitus Stupid VAS scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Sensorineural Hearing Loss
Keywords
Sudden Sensorineural Hearing Loss, Coenzyme I

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd.
Arm Title
Control Group
Arm Type
Other
Arm Description
Procedure: conventional treatment.
Intervention Type
Drug
Intervention Name(s)
Coenzyme I for Injection + conventional treatment
Intervention Description
The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Intervention Description
The control group was treated with conventional treatment
Primary Outcome Measure Information:
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Baseline, before treatment
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Treatment day 3
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Treatment day 7
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Treatment day 14
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Treatment day 30
Title
Pure Tone Average(PTA)
Description
Pure tone audiometry is the most basic and preferred hearing test method, which can qualitatively and quantitatively diagnose hearing loss, can reflect the entire auditory conduction pathway from the external ear to the auditory center, and is currently one of the subjective behavioral hearing tests that can accurately reflect hearing acuity. Includes pure tone air conduction hearing threshold test and pure tone bone hearing threshold test.
Time Frame
Treatment day 90
Secondary Outcome Measure Information:
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Baseline, before treatment
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Treatment day 3
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Treatment day 7
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Treatment day 14
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Treatment day 30
Title
Speech Recognition Rate
Description
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Time Frame
Treatment day 90
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Baseline, before treatment
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Treatment day 3
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Treatment day 7
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Treatment day 14
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Treatment day 30
Title
Tinnitus Handicap Inventory
Description
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life. Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Time Frame
Treatment day 90
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Baseline, before treatment
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Treatment day 3
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Treatment day 7
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Treatment day 14
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Treatment day 30
Title
Visual Analogue Scale of Tinnitus
Description
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Time Frame
Treatment day 90
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Baseline, before treatment
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Treatment day 3
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Treatment day 7
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Treatment day 14
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Treatment day 30
Title
Severity of ear fullness
Description
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Time Frame
Treatment day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18yrs.the 2019 American Sudden Deafness Guidelines are for patients with sudden deafness over 18 years of age; Patients diagnosed with sudden deafness, i.e. unexplained sensorineural hearing loss occurring within 72 hours, with hearing threshold ≥30 in at least 3 consecutive frequencies, refer to the 2019 American Sudden Deafness Guidelines; Unilateral sudden deafness; Within 1 week of the onset of sudden deafness, no treatment in another hospital/our hospital; No major neurological disease, serious systemic disease, family genetic history, major mental illness; Informed and agreed to join the experiment, no plan to move out or go out within 1 month. Exclusion Criteria: Other diseases such as acoustic neuroma diagnosed by imaging; Those who cannot tolerate NAD+; pregnant； Any other circumstances that the investigator believes should be excluded from this study； Do not agree to join the experiment, plan to move out or go out within 1 month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minqian Gao, B.Sc
Phone
13660778861
Email
gaomq6@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minqian Gao, B.sc
Phone
13660778861
Email
gaomq6@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss

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