Clinical trial NCT05849519: Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
Official title: Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Sudden Sensorineural Hearing Loss
Keywords: Sudden Sensorineural Hearing Loss
Coenzyme I
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pure Tone Average(PTA)
timeFrame: Baseline, before treatment
measure: Pure Tone Average(PTA)
timeFrame: Treatment day 3
measure: Pure Tone Average(PTA)
timeFrame: Treatment day 7
measure: Pure Tone Average(PTA)
timeFrame: Treatment day 14
measure: Pure Tone Average(PTA)
timeFrame: Treatment day 30
measure: Pure Tone Average(PTA)
timeFrame: Treatment day 90
Secondary outcomes:
measure: Speech Recognition Rate
timeFrame: Baseline, before treatment
measure: Speech Recognition Rate
timeFrame: Treatment day 3
measure: Speech Recognition Rate
timeFrame: Treatment day 7
measure: Speech Recognition Rate
timeFrame: Treatment day 14
measure: Speech Recognition Rate
timeFrame: Treatment day 30
measure: Speech Recognition Rate
timeFrame: Treatment day 90
measure: Tinnitus Handicap Inventory
timeFrame: Baseline, before treatment
measure: Tinnitus Handicap Inventory
timeFrame: Treatment day 3
measure: Tinnitus Handicap Inventory
timeFrame: Treatment day 7
measure: Tinnitus Handicap Inventory
timeFrame: Treatment day 14
measure: Tinnitus Handicap Inventory
timeFrame: Treatment day 30
measure: Tinnitus Handicap Inventory
timeFrame: Treatment day 90
measure: Visual Analogue Scale of Tinnitus
timeFrame: Baseline, before treatment
measure: Visual Analogue Scale of Tinnitus
timeFrame: Treatment day 3
measure: Visual Analogue Scale of Tinnitus
timeFrame: Treatment day 7
measure: Visual Analogue Scale of Tinnitus
timeFrame: Treatment day 14
measure: Visual Analogue Scale of Tinnitus
timeFrame: Treatment day 30
measure: Visual Analogue Scale of Tinnitus
timeFrame: Treatment day 90
measure: Severity of ear fullness
timeFrame: Baseline, before treatment
measure: Severity of ear fullness
timeFrame: Treatment day 3
measure: Severity of ear fullness
timeFrame: Treatment day 7
measure: Severity of ear fullness
timeFrame: Treatment day 14
measure: Severity of ear fullness
timeFrame: Treatment day 30
measure: Severity of ear fullness
timeFrame: Treatment day 90
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: