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

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Sensorineural Hearing Loss
• Intervention / Treatment: Drug: Coenzyme I for Injection + conventional treatment; Drug: Conventional treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Minqian Gao, B.sc; Phone Number: 13660778861; Email: gaomq6@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Minqian Gao, B.sc; Phone Number: 13660778861; Email: gaomq6@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd.	Drug: Coenzyme I for Injection + conventional treatment; The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days
Other: Control Group; Procedure: conventional treatment.	Drug: Conventional treatment; The control group was treated with conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Treatment day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Treatment day 90
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Treatment day 90

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Anticipated): February 16, 2024
• Study Completion (Anticipated): February 16, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Sudden Sensorineural Hearing Loss; Coenzyme I
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 2022-KY-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No