TinnitusNCT07887932
Multidimensional Phenotyping of Patients With Tinnitus Using Electronic Health Records and a Specialty Database
An observational study of Tinnitus, run by Eye & ENT Hospital of Fudan University.
Trial summary
This retrospective observational study will use historical electronic health record and tinnitus specialty database data from adult patients with tinnitus seen at the Eye and ENT Hospital of Fudan University between January 2015 and August 2026. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- How many people
- 225,792 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Aug 2026
- Phase
- Observational
- 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
Study population: Adults with tinnitus identified from the hospital tinnitus specialty database and electronic health record system. The database contains multidimensional demographic, symptom, audiometric, laboratory, imaging, comorbidity, treatment and longitudinal visit information.
Who may be able to join
- Patients who attended the Department of Otorhinolaryngology of the hospital affiliated to Fudan University between January 2015 and August 2026;
- A primary or secondary diagnosis of tinnitus;
- Age ≥ 18 years;
- At least one complete electronic health record, including basic demographic information and visit records.
Who cannot join
- Age < 18 years (data of underage patients are not included in this study);
- Duplicate visit records (only the first-visit record is retained; subsequent follow-up records are used for longitudinal analysis);
- Missing key demographic information (such as indeterminable sex or age);
- Data quality not meeting requirements (such as obvious entry errors or logical contradictions in key clinical indicators).
About this study
Official title: Multidimensional Characterisation and Phenotype Discovery in Patients With Tinnitus Based on Electronic Health Records and a Tinnitus Specialty Database
This retrospective observational study will use historical electronic health record and tinnitus specialty database data from adult patients with tinnitus seen at the Eye and ENT Hospital of Fudan University between January 2015 and August 2026. The study will identify multidimensional tinnitus phenotypes, examine relationships between subjective tinnitus severity and objective audiometric measures, explore within-phenotype heterogeneity, and assess longitudinal phenotype stability and outcome patterns using existing follow-up records. No intervention or additional examination will be performed.
- Conditions
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with tinnitus | Patients aged ≥18 years with a primary or secondary tinnitus diagnosis who attended the Department of Otorhinolaryngology of the Eye and ENT Hospital of Fudan University between January 2015 and August 2026 and had at least one complete electronic health record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tinnitus phenotypes identified
The number of distinct tinnitus phenotypes identified based on demographic characteristics, tinnitus symptoms, audiometric findings, laboratory test results, and comorbidity information recorded in the electronic health records and tinnitus specialty database.
Measured: Baseline
Secondary outcomes (13)
Tinnitus severity
Tinnitus severity measured using the Tinnitus Handicap Inventory (THI), with total scores ranging from 0 to 100.
Measured: Baseline
Tinnitus loudness
Self-reported tinnitus loudness measured using a visual analogue scale (VAS, 0-10).
Measured: Baseline
Pure-tone hearing thresholds
Pure-tone hearing thresholds measured in both ears at 250, 500, 1000, 2000, 4000, and 8000 Hz.
Measured: Baseline
Tinnitus duration
Duration of tinnitus recorded in the electronic health records or tinnitus specialty database.
Measured: Baseline
Tinnitus laterality
Tinnitus laterality recorded as part of the clinical tinnitus assessment.
Measured: Baseline
White blood cell count
White blood cell count obtained from complete blood count testing recorded in the electronic health records.
Measured: Baseline
Red blood cell count
Red blood cell count obtained from complete blood count testing recorded in the electronic health records.
Measured: Baseline
Haemoglobin concentration
Haemoglobin concentration obtained from complete blood count testing recorded in the electronic health records.
Measured: Baseline
Platelet count
Platelet count obtained from complete blood count testing recorded in the electronic health records.
Measured: Baseline
Differential white blood cell counts
Absolute counts or percentages of neutrophils, lymphocytes, monocytes, eosinophils, and basophils, as available in the electronic health records.
Measured: Baseline
Biochemistry panel
Biochemical measurements including liver function, kidney function, blood lipids, blood glucose, and electrolytes.
Measured: Baseline
Ear CT
Findings from ear computed tomography examinations, when available.
Measured: Baseline
Ear MRI
Findings from ear magnetic resonance imaging examinations, when available.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2015
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 225,792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887932
- Sponsor's protocol ID
- 2026228
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Characterisation and Phenotype Discovery in Patients With Tinnitus Based on Electronic Health Records and a Tinnitus Specialty Database
- ClinicalTrials.gov ID
- NCT07887932
- Acronym / sponsor ID
- 2026228
- Conditions
- Tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225,792 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 22 Oct 2026 (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.
This retrospective observational study will use historical electronic health record and tinnitus specialty database data from adult patients with tinnitus seen at the Eye and ENT Hospital of Fudan University between January 2015 and August 2026. The study will identify multidimensional tinnitus phenotypes, examine relationships between subjective tinnitus severity and objective audiometric measures, explore within-phenotype heterogeneity, and assess longitudinal phenotype stability and outcome patterns using existing follow-up records. No intervention or additional examination will be performed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with tinnitus | – | –Patients aged ≥18 years with a primary or secondary tinnitus diagnosis who attended the Department of Otorhinolaryngology of the Eye and ENT Hospital of Fudan University between January 2015 and August 2026 and had at least one complete electronic health record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with tinnitus identified from the hospital tinnitus specialty database and electronic health record system. The database contains multidimensional demographic, symptom, audiometric, laboratory, imaging, comorbidity, treatment and longitudinal visit information.
Key inclusion criteria (4 listed)
- Patients who attended the Department of Otorhinolaryngology of the hospital affiliated to Fudan University between January 2015 and August 2026;
- A primary or secondary diagnosis of tinnitus;
- Age ≥ 18 years;
- At least one complete electronic health record, including basic demographic information and visit records.
Key exclusion criteria (4 listed)
- Age < 18 years (data of underage patients are not included in this study);
- Duplicate visit records (only the first-visit record is retained; subsequent follow-up records are used for longitudinal analysis);
- Missing key demographic information (such as indeterminable sex or age);
- Data quality not meeting requirements (such as obvious entry errors or logical contradictions in key clinical indicators).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of tinnitus phenotypes identified
Time frame: Baseline
The number of distinct tinnitus phenotypes identified based on demographic characteristics, tinnitus symptoms, audiometric findings, laboratory test results, and comorbidity information recorded in the electronic health records and tinnitus specialty database.
13 secondary outcomes
Tinnitus severity
Time frame: Baseline
Tinnitus loudness
Time frame: Baseline
Pure-tone hearing thresholds
Time frame: Baseline
Tinnitus duration
Time frame: Baseline
Tinnitus laterality
Time frame: Baseline
White blood cell count
Time frame: Baseline
Red blood cell count
Time frame: Baseline
Haemoglobin concentration
Time frame: Baseline
Platelet count
Time frame: Baseline
Differential white blood cell counts
Time frame: Baseline
Biochemistry panel
Time frame: Baseline
Ear CT
Time frame: Baseline
Ear MRI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Eye & ENT Hospital of Fudan University.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tinnitus phenotypes identified (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.