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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days
The control group was treated with conventional treatment
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGPure 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.
Time frame: Baseline, before treatment
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.
Time frame: Treatment day 3
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.
Time frame: Treatment day 7
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.
Time frame: Treatment day 14
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.
Time frame: Treatment day 30
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.
Time frame: Treatment day 90
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.
Time frame: Baseline, before treatment
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.
Time frame: Treatment day 3
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.
Time frame: Treatment day 7
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.
Time frame: Treatment day 14
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.
Time frame: Treatment day 30
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.
Time frame: Treatment day 90
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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.
Time frame: Baseline, before treatment
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.
Time frame: Treatment day 3
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.
Time frame: Treatment day 7
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.
Time frame: Treatment day 14
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.
Time frame: Treatment day 30
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.
Time frame: Treatment day 90
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.
Time frame: Baseline, before treatment
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.
Time frame: Treatment day 3
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.
Time frame: Treatment day 7
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.
Time frame: Treatment day 14
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.
Time frame: Treatment day 30
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.
Time frame: Treatment day 90
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.
Time frame: Baseline, before treatment
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.
Time frame: Treatment day 3
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.
Time frame: Treatment day 7
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.
Time frame: Treatment day 14
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.
Time frame: Treatment day 30
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.
Time frame: Treatment day 90