OtosclerosisOtosclerosisNCT06022471
Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram
An observational study of Otosclerosis, run by Assiut University.
Trial summary
This study will be conducted on patients with otosclerosis attending Assiut University Hospital and undergo stapedectomy operation Evaluation of each patient will conducted preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otosclerosis
- What is being tested?
- Stapes surgery
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 15 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with conductive hearing loss associated with tinnitus
Who may be able to join
- patient with otosclerosis undergo stapes surgery in otorhinology department in Assiut university hospital
- All patient have tinnitus and conductive hearing loss or mixed hearing loss.
Who cannot join
- patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due to causes other than otosclerosis.
Trial locations and contacts
No sites are listed yet.
AssiutU Hospital contact
About this study
Official title: Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus
This study will be conducted on patients with otosclerosis attending Assiut University Hospital and undergo stapedectomy operation Evaluation of each patient will conducted preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to measure improvement in hearing and tinnitus
Read the detailed description
Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone leading to the fixation of the stapes.
- Clinical otosclerosis is more prevalent in females than in males, giving rise to the hypothesis that sex hormones may contribute to the development of disease
- The age of onset is variable, although hearing loss typically begins in the third decade, with a range from first decade to the sixth decade.
In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing initially in one ear before progressing to the other.
Positive family history of otosclerosis has been previously reported in between 30-70% of cases.
The diagnosis is usually made clinically by
- History
- Physical examination,
- Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most frequent presentation of patients with clinical otosclerosis is bilateral hearing loss and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus. patients with tinnitus often report that their tinnitus is associated with feelings of sadness, worry, frustration, and anger.
These feelings can lead to difficulties sleeping, relaxing, and concentrating and may negatively impact relationships at work and impair participation in social settings .
Stapedotomy through sufficient air-bone gap closure Data collection
- full history taking
- tinnitus handicap questionnaire arabic version
- Vital signs and general examination
- Full ENT examination including ear canal and tympanic membrane examination
- Routine audiologic testing which provide an assessment of patient hearing
- Investigation
- Preoperative fitness
- Tinnitogra
Tinnitogram :
Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency.
Tinnitus loudness match : patient threshold was determined at frequency of pitch matching, sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version
- Conditions
- Otosclerosis
- Being tested
- Stapes surgery
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapes surgeryProcedure or surgery
Stapedectomy operation
| Study group | Role | What they receive |
|---|---|---|
| Stapes surgery | Not described Receives: Procedure: Stapes surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease tinnitus
Measuring tinnitus by tinnitogram By pure tone averages untile patients report that specific tone resemble their tinnitus The unit of measure for sound intensity is the decibel (dB)
Measured: 3 month
Secondary outcomes (1)
Changes in pure tone averages
Pure tone averages calculated from pure tone audiometry will be summarized using the mean
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Araby Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022471
- Sponsor's protocol ID
- Outcome of ss in ot
- Acronym
- Otosclerosis
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT06022471
- Acronym / sponsor ID
- Otosclerosis / Outcome of ss in ot
- Conditions
- Otosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 5 Sep 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.
This study will be conducted on patients with otosclerosis attending Assiut University Hospital and undergo stapedectomy operation Evaluation of each patient will conducted preoperatively and 3 month postoperatively Patient will undergo tinnitogram and tinnitus handicap questionnaire before and after the operation to measure improvement in hearing and tinnitus
Detailed description
Otosclerosis is an abnormal bone remodeling in the middle ear The normal dense endochondral layer of the bony otic capsule in the labyrinth is replaced by irregularly laid spongy bone leading to the fixation of the stapes.
- Clinical otosclerosis is more prevalent in females than in males, giving rise to the hypothesis that sex hormones may contribute to the development of disease
- The age of onset is variable, although hearing loss typically begins in the third decade, with a range from first decade to the sixth decade.
In most cases, hearing loss is bilateral (70-85%) and is usually asymmetrical, developing initially in one ear before progressing to the other.
Positive family history of otosclerosis has been previously reported in between 30-70% of cases.
The diagnosis is usually made clinically by
- History
- Physical examination,
- Audiogram results(tinnitus handicap questionnaire arabic version, tinnnitogram ) most frequent presentation of patients with clinical otosclerosis is bilateral hearing loss and tinnitus Between 65 and 87% of patient with otosclerosis experience tinnitus. most of them has unilateral tinnitus 83.3% , while only 16.7% reported bilateral tinnitus. patients with tinnitus often report that their tinnitus is associated with feelings of sadness, worry, frustration, and anger.
These feelings can lead to difficulties sleeping, relaxing, and concentrating and may negatively impact relationships at work and impair participation in social settings .
Stapedotomy through sufficient air-bone gap closure Data collection
- full history taking
- tinnitus handicap questionnaire arabic version
- Vital signs and general examination
- Full ENT examination including ear canal and tympanic membrane examination
- Routine audiologic testing which provide an assessment of patient hearing
- Investigation
- Preoperative fitness
- Tinnitogra
Tinnitogram :
Tinnitus pitch match : we will start at 1000 Hz and move up and down in frequency.
Tinnitus loudness match : patient threshold was determined at frequency of pitch matching, sound level will increase in small steps(1or 2 dB ) until patient repoted that specific tone will just equal in loudeness to his tinnitus Tinnitus handicap questionnaire arabic version
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapes surgery | – | Procedure: Stapes surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with conductive hearing loss associated with tinnitus
Key inclusion criteria (2 listed)
- patient with otosclerosis undergo stapes surgery in otorhinology department in Assiut university hospital
- All patient have tinnitus and conductive hearing loss or mixed hearing loss.
Key exclusion criteria (1 listed)
- patient with otosclerosis who don't undergo stapes surgery patient have tinnitus due to causes other than otosclerosis.
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 |
|---|---|---|
| Stapes surgeryStapedectomy operation | Procedure or surgery | Stapes surgery |
Primary outcome
decrease tinnitus
Time frame: 3 month
Measuring tinnitus by tinnitogram By pure tone averages untile patients report that specific tone resemble their tinnitus The unit of measure for sound intensity is the decibel (dB)
1 secondary outcome
Changes in pure tone averages
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
AssiutU Hospital contact
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis, run by Assiut 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 2 inclusion and 1 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 5 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Araby (01119015094, doaaaraby9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease tinnitus (time frame: 3 month). 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 5 Sep 2023.