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

• Status: Recruiting
• Trial end date: 2024-02-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.