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

Last updated: May 8, 2023
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

1

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

Coenzyme I for Injection + conventional treatment

Conventional treatment

Clinical Study ID

NCT05849519
2022-KY-004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18yrs.the 2019 American Sudden Deafness Guidelines are for patients with suddendeafness over 18 years of age;
  2. Patients diagnosed with sudden deafness, i.e. unexplained sensorineural hearing lossoccurring within 72 hours, with hearing threshold ≥30 in at least 3 consecutivefrequencies, 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/ourhospital;
  5. No major neurological disease, serious systemic disease, family genetic history, majormental illness;
  6. Informed and agreed to join the experiment, no plan to move out or go out within 1month.

Exclusion

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 thisstudy;
  5. Do not agree to join the experiment, plan to move out or go out within 1 month.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Coenzyme I for Injection + conventional treatment
Phase: 1
Study Start date:
February 16, 2022
Estimated Completion Date:
February 16, 2024

Study 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.

Connect with a study center

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

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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