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

NCT ID: NCT05849519

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2024-02-16

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.

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.

Conditions

Sudden Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Coenzyme I for Injection + conventional treatment

Intervention Type: DRUG

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

Control Group

Procedure: conventional treatment.

Group Type: OTHER

Conventional treatment

Intervention Type: DRUG

The control group was treated with conventional treatment

Interventions

Coenzyme I for Injection + conventional treatment

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

Intervention Type: DRUG

Conventional treatment

The control group was treated with conventional treatment

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Minqian Gao, B.Sc

Role: CONTACT

gaomq6@mail.sysu.edu.cn

13660778861

Facility Contacts

Minqian Gao, B.sc

Role: primary

gaomq6@mail.sysu.edu.cn

13660778861

Other Identifiers

2022-KY-004

Identifier Type: -

Identifier Source: org_study_id