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

NCTNCT05849519Other id2022-KY-004

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Overview

Status: Status unknown
Phase: Early phase 1
Enrollment: 36 participants (estimated)
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Design: Randomized · Single masking
Countries: 1 country
China
Start: 16 Feb 2022
Primary completion: 16 Feb 2024 (estimated)
Completion: 16 Feb 2024 (estimated)
First posted: 9 May 2023
Last update posted: 9 May 2023
Conditions: Sudden Sensorineural Hearing Loss

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph Early 1
Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
NCT05849519
16 Feb 2022 to est. 16 Feb 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Coenzyme I for Injection + conventional treatmentDrug
Conventional treatmentDrug

Arms2

Experimental
Intervention Group
Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd.
Other
Control Group
Procedure: conventional treatment.

Primary outcomes6

Outcomes the sponsor listed as primary.

Pure Tone Average(PTA)
Time frame · Baseline, before treatment
Registry 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.
Pure Tone Average(PTA)
Time frame · Treatment day 3
Registry 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.
Pure Tone Average(PTA)
Time frame · Treatment day 7
Registry 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.
Pure Tone Average(PTA)
Time frame · Treatment day 14
Registry 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.
Pure Tone Average(PTA)
Time frame · Treatment day 30
Registry 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.
Pure Tone Average(PTA)
Time frame · Treatment day 90
Registry 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.

Secondary outcomes(20)

Speech Recognition Rate
Time frame · Baseline, before treatment
Registry 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.
Speech Recognition Rate
Time frame · Treatment day 3
Registry 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.
Speech Recognition Rate
Time frame · Treatment day 7
Registry 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.
Speech Recognition Rate
Time frame · Treatment day 14
Registry 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.
Speech Recognition Rate
Time frame · Treatment day 30
Registry 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.
Speech Recognition Rate
Time frame · Treatment day 90
Registry 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.
Tinnitus Handicap Inventory
Time frame · Baseline, before treatment
Registry 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.
Tinnitus Handicap Inventory
Time frame · Treatment day 3
Registry 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.
Tinnitus Handicap Inventory
Time frame · Treatment day 7
Registry 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.
Tinnitus Handicap Inventory
Time frame · Treatment day 14
Registry 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.
Tinnitus Handicap Inventory
Time frame · Treatment day 30
Registry 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.
Tinnitus Handicap Inventory
Time frame · Treatment day 90
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Baseline, before treatment
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Treatment day 3
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Treatment day 7
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Treatment day 14
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Treatment day 30
Registry 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.
Visual Analogue Scale of Tinnitus
Time frame · Treatment day 90
Registry 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.
Severity of ear fullness
Time frame · Baseline, before treatment
Registry 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.
Severity of ear fullness
Time frame · Treatment day 3
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedGao M, Guan Y, Yue X, Bao H, Li Q, Zheng Y, Ou Y, Yang H. NAD+ Enhanced on Hearing Recovery in Sudden Sensorineural Hearing Loss: Randomized Controlled Trial. Laryngoscope. 2026 Mar;136(3):1204-1214. doi: 10.1002/lary.70173. Epub 2025 Oct 1. PMID 41035311

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age ≥18yrs.the 2019 American Sudden Deafness Guidelines are for patients with sudden deafness over 18 years of age; 2. 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; 3. Unilateral sudden deafness; 4. Within 1 week of the onset of sudden deafness, no treatment in another hospital/our hospital; 5. No major neurological disease, serious systemic disease, family genetic history, major mental illness; 6. Informed and agreed to join the experiment, no plan to move out or go out within 1 month. Exclusion Criteria: 1. Other diseases such as acoustic neuroma diagnosed by imaging; 2. Those who cannot tolerate NAD+; 3. pregnant； 4. Any other circumstances that the investigator believes should be excluded from this study； 5. Do not agree to join the experiment, plan to move out or go out within 1 month.

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