Sudden Sensorineural Hearing LossEarly Phase 1NCT05849519
Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
A Early Phase 1 study testing Coenzyme I for Injection + conventional treatment and Conventional treatment in people with Sudden Sensorineural Hearing Loss, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- Coenzyme I for Injection + conventional treatment and Conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2022to 16 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Minqian Gao, B.sc, 13660778861, gaomq6@mail.sysu.edu.cn
About this study
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.
Read the 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
- Being tested
- Coenzyme I for Injection + conventional treatment, Conventional treatment
- Keywords
- Sudden Sensorineural Hearing Loss, Coenzyme I
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme I for Injection + conventional treatmentDrug
The intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days
Conventional treatmentDrug
The control group was treated with conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Procedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd. Receives: Drug: Coenzyme I for Injection + conventional treatment |
| Control Group | Other | Procedure: conventional treatment. Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Treatment day 90
Secondary outcomes (24)
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Baseline, before treatment
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Treatment day 3
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Treatment day 7
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Treatment day 14
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Treatment day 30
Speech Recognition Rate
The speech recognition rate is the percentage (%) of speech which can be heard correctly in the audiometric vocabulary list, and the curve is drawn according to the (%) understood by different sound intensity levels, that is, the speech audiogram.
Measured: Treatment day 90
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Baseline, before treatment
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Treatment day 3
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Treatment day 7
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Treatment day 14
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Treatment day 30
Tinnitus Handicap Inventory
The Tinnitus Handicap Inventory (THI) is a tool to measure the impact of tinnitus on daily life.
Yes (always has): 4 points; Sometimes (intermittent presence): 2 points.None: 0 points; None:0 points. Divide tinnitus into grade 5 I (mild), THI score 1~16 divide; Grade 2 (mild), THI score 18~36 points; Level 3 (moderate), THI score 38~56 points; Level 4 (severe), THI score 58~76 points; Level 5 (catastrophic), THI score 78~100 points.
Measured: Treatment day 90
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Baseline, before treatment
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Treatment day 3
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Treatment day 7
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Treatment day 14
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Treatment day 30
Visual Analogue Scale of Tinnitus
VAS (Visual Analogue Scale) is a tool to detect changes in the subjective loudness of tinnitus. 0 represents no tinnitus loudness at all, 10 represents the presence of extremely severe loudness, and the middle represents different degrees of tinnitus loudness.
Measured: Treatment day 90
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Baseline, before treatment
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Treatment day 3
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Treatment day 7
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Treatment day 14
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Treatment day 30
Severity of ear fullness
Visual Analogue Scale(VAS).0 represents no ear stuffiness at all, 10 represents the presence of extremely severe ear stuffiness, and the middle represents different degrees of ear stuffiness.
Measured: Treatment day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start16 Feb 2022
- Primary completion16 Feb 2024 (estimated)
- Study completion16 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849519
- Sponsor's protocol ID
- 2022-KY-004
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao M, Guan Y, Yue X, Bao H, Li Q, Zheng Y, Ou Y, Yang H. NAD+ Enhanced on Hearing Recovery in Sudden Sensorineural Hearing Loss: Randomized Controlled Trial. Laryngoscope. 2026 Mar;136(3):1204-1214. doi: 10.1002/lary.70173. Epub 2025 Oct 1.
PubMed 41035311
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT05849519
- Acronym / sponsor ID
- 2022-KY-004
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- Sudden Sensorineural Hearing Loss, Coenzyme I
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 16 Feb 2024 (estimated)
- Study completion
- 16 Feb 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Coenzyme I for Injection + conventional treatmentProcedure:Coenzyme I for Injection,5mg，im，qd；Nacl，2ml，im，qd. |
| Control Group | Other | Drug: Conventional treatmentProcedure: conventional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme I for Injection + conventional treatmentThe intervention group used Coenzyme I for injection and conventional treatment for 7 consecutive days | Drug | Intervention Group |
| Conventional treatmentThe control group was treated with conventional treatment | Drug | Control Group |
Primary outcome
Pure Tone Average(PTA)
Time frame: Baseline, before treatment
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.
Pure Tone Average(PTA)
Time frame: Treatment day 3
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.
Pure Tone Average(PTA)
Time frame: Treatment day 7
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.
Pure Tone Average(PTA)
Time frame: Treatment day 14
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.
Pure Tone Average(PTA)
Time frame: Treatment day 30
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.
Pure Tone Average(PTA)
Time frame: Treatment day 90
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.
24 secondary outcomes
Speech Recognition Rate
Time frame: Baseline, before treatment
Speech Recognition Rate
Time frame: Treatment day 3
Speech Recognition Rate
Time frame: Treatment day 7
Speech Recognition Rate
Time frame: Treatment day 14
Speech Recognition Rate
Time frame: Treatment day 30
Speech Recognition Rate
Time frame: Treatment day 90
Tinnitus Handicap Inventory
Time frame: Baseline, before treatment
Tinnitus Handicap Inventory
Time frame: Treatment day 3
Tinnitus Handicap Inventory
Time frame: Treatment day 7
Tinnitus Handicap Inventory
Time frame: Treatment day 14
Tinnitus Handicap Inventory
Time frame: Treatment day 30
Tinnitus Handicap Inventory
Time frame: Treatment day 90
Visual Analogue Scale of Tinnitus
Time frame: Baseline, before treatment
Visual Analogue Scale of Tinnitus
Time frame: Treatment day 3
Visual Analogue Scale of Tinnitus
Time frame: Treatment day 7
Visual Analogue Scale of Tinnitus
Time frame: Treatment day 14
Visual Analogue Scale of Tinnitus
Time frame: Treatment day 30
Visual Analogue Scale of Tinnitus
Time frame: Treatment day 90
Severity of ear fullness
Time frame: Baseline, before treatment
Severity of ear fullness
Time frame: Treatment day 3
Severity of ear fullness
Time frame: Treatment day 7
Severity of ear fullness
Time frame: Treatment day 14
Severity of ear fullness
Time frame: Treatment day 30
Severity of ear fullness
Time frame: Treatment day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 41035311Gao M, Guan Y, Yue X, Bao H, Li Q, Zheng Y, Ou Y, Yang H. NAD+ Enhanced on Hearing Recovery in Sudden Sensorineural Hearing Loss: Randomized Controlled Trial. Laryngoscope. 2026 Mar;136(3):1204-1214. doi: 10.1002/lary.70173. Epub 2025 Oct 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Coenzyme I for Injection + conventional treatment and Conventional treatment in people with Sudden Sensorineural Hearing Loss, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minqian Gao, B.Sc (13660778861, gaomq6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure Tone Average(PTA) (time frame: Baseline, before treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.