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

NCT05849519 | Unknown Early Phase 1

• 1 other identifier: 2022-KY-004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Sensorineural Hearing Loss

Keywords

Sudden Sensorineural Hearing Loss; Coenzyme I

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (24)

• Speech Recognition Rate

  Baseline, before treatment

• Speech Recognition Rate

  Treatment day 3

• Speech Recognition Rate

  Treatment day 7

• Speech Recognition Rate

  Treatment day 14

• Speech Recognition Rate

  Treatment day 30

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Drug: Coenzyme I for Injection + conventional treatment

Control Group

OTHER

Procedure: conventional treatment.

Drug: Conventional treatment

Interventions

Coenzyme I for Injection + conventional treatment DRUG

The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days

Intervention Group

Conventional treatment DRUG

The control group was treated with conventional treatment

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

NAD; Injections

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Minqian Gao, B.Sc

CONTACT

13660778861; gaomq6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: May 9, 2023
• Study Start: February 16, 2022
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: May 9, 2023

Record last verified: 2022-08

Locations

CN (1)