Idiopathic Sudden SNHLPhase 2NCT05112354
Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss
A Phase 2 study testing systemic and intratympanic injection of steoid in people with Idiopathic Sudden SNHL, run by Assiut University at 1 site in Egypt.
Trial summary
Sudden sensorineural hearing loss (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was… Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Idiopathic Sudden SNHL
- What is being tested?
- systemic and intratympanic injection of steoid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 30 Jun 2021
- Phase
- Phase 2
- 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 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All cases above 6 years presented with unilateral or bilateral ISSNHL
Who cannot join
- Patient below 6 years old
Trial locations and contacts
1 site in 1 country.
About this study
Sudden sensorineural hearing loss (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was 5-27/100,000 persons per year in the United states.2,3 The causative etiologies for SSNHL included viruses, microcirculation abnormalities, and autoimmune disorders. However, definitive evidence remains elusive.4,5 Currently, steroids are the treatment of choice due to their effects on the inner ear such as immunosuppression and circular enhancement.6,7 Combined systemic and intra-tympanic steroid treatment has previously been reported to be beneficial for SSNHL patients, with overall better treatment outcomes.8,9 However, due to the heterogeneous pathological nature and spontaneous recovery potential of the disease, few controlled studies exist in the literature. As a result, the treatment strategies of SSNHL remain a controversial issue in clinicalpractice .10 The condition exhibits a wide age distribution , with an average of 50-60 years and no sex preference. The hearing loss is unilateral in most Population studies of sudden sensorineural hearing loss cases, with bilateral involvement reported in less than 5%. 11 The severity of the hearing loss is divided roughly equally into mild, moderate, and severe profound. The configuration of the hearing loss varies and can affect high, low, or all frequencies. Tinnitus occurs in about 80% of patients, and vertigo, indicating an associated peripheral vestibular dysfunction, in about 30%. 12 The response to medical therapy shows inconsistent results regarding symptoms especially hearing loss may be due to the uncertainty about the cause of the disease and its progress. little is known about the factors which may contribute to either success or failure of the medical therapy.
Aim of work
- To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL
- To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.
Read the detailed description
Patient and methods Study design The study will be conducted as across sectional observation study. Study setting ENT Department Assiut University Hospital outpatient clinic in the period between the 1st July 2019 end of June 2021.
Inclusion criteria All cases above 6 years presented with unilateral or bilateral ISSNHL Exclusion criteria Patient below 6 years old.
Data Collection
After fulfilling all inclusion and exclusion criteria all the patient will be subjected to:
- Full History taking including : the residency, occupation, duration of the clinical symptoms , associated symptoms like tinnitus , vertigo and aural fullness, the presence of previous episodes of hearing loss, the presence of any chronic medical condition especially diabetes and hypertension and neurological history, the medication history and surgical history specially ear surgeries, in addition to family history if relevant.
- Full medical examination including general examination with special emphasizing upon blood pressure measurements, full neurological examination, full ENT examination with vestibular testing especially in cases presented with vertigo
- Laboratory investigation Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
Renal function test Liver function test. Random blood sugar, oral glucose testing, HbA1c
audiological evaluation upon recruitment, all the patient will be subjected to audiological evaluation using audiogram where the hearing loss will be graded into mild, moderate, , sever and profound. speech discrimition will be graded into good ,fair and poor upon recruitment, all the patient will be subjected to audiological evaluation using ABR to asses retrocochlear pathology
Management plan
- If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
- Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.
An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.
Follow up All the patient will be subjected to audiological evaluation using the audiogram 2 weeks and one month after the initiation of the therapy to detect the treatment outcome.
Statistical analysis
- Factors affecting the treatment outcome will be grouped into
- Age.
- Onset of the disease.
- . tinnitus.
- vertigo.
- audiogram to detect the degree of hearing loss mild,moderate severe profund .speech discrimition low frequencies versus high frequencies.
- Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
- Comorbidities as hypertension cardiac All those factors will be compared to each other and to the final hearing outcome using correlation coefficient, regression analysis using the SPSS 20 software. Ethical consideration: . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval. The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy. Privacy and confidentiality of all data will be assured .
- The aim of the study will be explained to each patient before the beginning of theprocess.
Written consent will be obtained from those who are willing to participate in the study.
Privacy and confidentiality of all data will be assured .
- Privacy and confidentiality of all data will be assured .
- . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval.
The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy.
Privacy and confidentiality of all data will be assured .
- The aim of the study will be explained to each patient before the beginning of theprocess.
Written consent will be obtained from those who are willing to participate in the study.
Privacy and confidentiality of all data will be assured .
- Privacy and confidentiality of all data will be assured .
- Conditions
- Idiopathic Sudden SNHL
- Being tested
- systemic and intratympanic injection of steoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic and intratympanic injection of steoidDrug
Also called Microscopic Intratympanic steroid injection
-If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
2-Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.
An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.
| Study group | Role | What they receive |
|---|---|---|
| the main group | Experimental | Management plan
1. If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
2. Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.
An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator Receives: Drug: systemic and intratympanic injection of steoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel )
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis( in decibel) assessed by audiogram pre and post treatment
Measured: 18months
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases and chronic kidney disease ) affect the final hearing prognosis in decibel
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases) from history taking affect the final hearing prognosis measured by decibel assessed by audiogram pre and post treatment
Measured: 18months
To detect if the severity of hearing loss symptoms in (decibel ) affect final hearing prognosis ( in decibel )
To detect if the degree of hearing loss symptoms in (decibel) affect final hearing assessed by audiogram pre and post treatmentprognosis ( in s assessed by audiogram pre and post treatment
Measured: 18 months
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis ( in decibel) assessed by audiogram pre and post treatment
Measured: 18 months
Secondary outcomes (2)
To detect if the age in years affect the final hearing prognosis
To detect if the age in years affect the final hearing prognosis assessed by audiogram pre and post treatment
Measured: 18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis
to detect if unilateral or bilateral symptoms affect the final hearing prognosis assessed by pre and post treatment audiogram
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Dec 2019
- Primary completion1 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Sudden SNHLStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- -If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks. 2-Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore. An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suhaib abdelzaker Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112354
- Sponsor's protocol ID
- Predictive factors in ISSNHL
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2019
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schreiber BE, Agrup C, Haskard DO, Luxon LM. Sudden sensorineural hearing loss. Lancet. 2010 Apr 3;375(9721):1203-11. doi: 10.1016/S0140-6736(09)62071-7.
PubMed 20362815Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
PubMed 22383545Lin HC, Lee HC, Chao PZ, Wu CS. The effects of weather on the incidence of sudden sensorineural hearing loss: a 5-year population-based study. Audiol Neurootol. 2006;11(3):165-71. doi: 10.1159/000091268. Epub 2006 Feb 1.
PubMed 16462137Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
PubMed 6325838Wei BP, Stathopoulos D, O'Leary S. Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev. 2013 Jul 2;2013(7):CD003998. doi: 10.1002/14651858.CD003998.pub3.
PubMed 23818120Trune DR, Canlon B. Corticosteroid therapy for hearing and balance disorders. Anat Rec (Hoboken). 2012 Nov;295(11):1928-43. doi: 10.1002/ar.22576. Epub 2012 Oct 8.
PubMed 23044978Lalaki P, Markou K, Tsalighopoulos MG, Daniilidis I. Transiently evoked otoacoustic emissions as a prognostic indicator in idiopathic sudden hearing loss. Scand Audiol Suppl. 2001;(52):141-5. doi: 10.1080/010503901300007344.
PubMed 11318448Han X, Yin X, Du X, Sun C. Combined Intratympanic and Systemic Use of Steroids as a First-Line Treatment for Sudden Sensorineural Hearing Loss: A Meta-Analysis of Randomized, Controlled Trials. Otol Neurotol. 2017 Apr;38(4):487-495. doi: 10.1097/MAO.0000000000001361.
PubMed 28207624Jung da J, Park JH, Jang JH, Lee KY. The efficacy of combination therapy for idiopathic sudden sensorineural hearing loss. Laryngoscope. 2016 Aug;126(8):1871-6. doi: 10.1002/lary.25751. Epub 2016 Mar 12.
PubMed 26972103Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol. 2013 Dec;34(9):1586-9. doi: 10.1097/MAO.0000000000000222.
PubMed 24232060Arslan N, Oguz H, Demirci M, Safak MA, Islam A, Kaytez SK, Samim E. Combined intratympanic and systemic use of steroids for idiopathic sudden sensorineural hearing loss. Otol Neurotol. 2011 Apr;32(3):393-7. doi: 10.1097/MAO.0b013e318206fdfa.
PubMed 21221047Hu A, Parnes LS. Intratympanic steroids for inner ear disorders: a review. Audiol Neurootol. 2009;14(6):373-82. doi: 10.1159/000241894. Epub 2009 Nov 16.
PubMed 19923807
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss
- ClinicalTrials.gov ID
- NCT05112354
- Acronym / sponsor ID
- Predictive factors in ISSNHL
- Conditions
- Idiopathic Sudden SNHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Nov 2021 (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 (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was 5-27/100,000 persons per year in the United states.2,3 The causative etiologies for SSNHL included viruses, microcirculation abnormalities, and autoimmune disorders. However, definitive evidence remains elusive.4,5 Currently, steroids are the treatment of choice due to their effects on the inner ear such as immunosuppression and circular enhancement.6,7 Combined systemic and intra-tympanic steroid treatment has previously been reported to be beneficial for SSNHL patients, with overall better treatment outcomes.8,9 However, due to the heterogeneous pathological nature and spontaneous recovery potential of the disease, few controlled studies exist in the literature. As a result, the treatment strategies of SSNHL remain a controversial issue in clinicalpractice .10 The condition exhibits a wide age distribution , with an average of 50-60 years and no sex preference. The hearing loss is unilateral in most Population studies of sudden sensorineural hearing loss cases, with bilateral involvement reported in less than 5%. 11 The severity of the hearing loss is divided roughly equally into mild, moderate, and severe profound. The configuration of the hearing loss varies and can affect high, low, or all frequencies. Tinnitus occurs in about 80% of patients, and vertigo, indicating an associated peripheral vestibular dysfunction, in about 30%. 12 The response to medical therapy shows inconsistent results regarding symptoms especially hearing loss may be due to the uncertainty about the cause of the disease and its progress. little is known about the factors which may contribute to either success or failure of the medical therapy.
Aim of work
- To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL
- To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.
Detailed description
Patient and methods Study design The study will be conducted as across sectional observation study. Study setting ENT Department Assiut University Hospital outpatient clinic in the period between the 1st July 2019 end of June 2021.
Inclusion criteria All cases above 6 years presented with unilateral or bilateral ISSNHL Exclusion criteria Patient below 6 years old.
Data Collection
After fulfilling all inclusion and exclusion criteria all the patient will be subjected to:
- Full History taking including : the residency, occupation, duration of the clinical symptoms , associated symptoms like tinnitus , vertigo and aural fullness, the presence of previous episodes of hearing loss, the presence of any chronic medical condition especially diabetes and hypertension and neurological history, the medication history and surgical history specially ear surgeries, in addition to family history if relevant.
- Full medical examination including general examination with special emphasizing upon blood pressure measurements, full neurological examination, full ENT examination with vestibular testing especially in cases presented with vertigo
- Laboratory investigation Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
Renal function test Liver function test. Random blood sugar, oral glucose testing, HbA1c
audiological evaluation upon recruitment, all the patient will be subjected to audiological evaluation using audiogram where the hearing loss will be graded into mild, moderate, , sever and profound. speech discrimition will be graded into good ,fair and poor upon recruitment, all the patient will be subjected to audiological evaluation using ABR to asses retrocochlear pathology
Management plan
- If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
- Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.
An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.
Follow up All the patient will be subjected to audiological evaluation using the audiogram 2 weeks and one month after the initiation of the therapy to detect the treatment outcome.
Statistical analysis
- Factors affecting the treatment outcome will be grouped into
- Age.
- Onset of the disease.
- . tinnitus.
- vertigo.
- audiogram to detect the degree of hearing loss mild,moderate severe profund .speech discrimition low frequencies versus high frequencies.
- Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
- Comorbidities as hypertension cardiac All those factors will be compared to each other and to the final hearing outcome using correlation coefficient, regression analysis using the SPSS 20 software. Ethical consideration: . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval. The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy. Privacy and confidentiality of all data will be assured .
- The aim of the study will be explained to each patient before the beginning of theprocess.
Written consent will be obtained from those who are willing to participate in the study.
Privacy and confidentiality of all data will be assured .
- Privacy and confidentiality of all data will be assured .
- . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval.
The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy.
Privacy and confidentiality of all data will be assured .
- The aim of the study will be explained to each patient before the beginning of theprocess.
Written consent will be obtained from those who are willing to participate in the study.
Privacy and confidentiality of all data will be assured .
- Privacy and confidentiality of all data will be assured .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- -If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks. 2-Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore. An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.
| Arm | Type | Receives |
|---|---|---|
| the main group | Experimental | Drug: systemic and intratympanic injection of steoidManagement plan 1. If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks. 2. Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore. An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All cases above 6 years presented with unilateral or bilateral ISSNHL
Key exclusion criteria (1 listed)
- Patient below 6 years old
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 |
|---|---|---|
| systemic and intratympanic injection of steoidAlso: Microscopic Intratympanic steroid injection-If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks. 2-Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore. An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator. | Drug | the main group |
Primary outcome
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel )
Time frame: 18months
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis( in decibel) assessed by audiogram pre and post treatment
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases and chronic kidney disease ) affect the final hearing prognosis in decibel
Time frame: 18months
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases) from history taking affect the final hearing prognosis measured by decibel assessed by audiogram pre and post treatment
To detect if the severity of hearing loss symptoms in (decibel ) affect final hearing prognosis ( in decibel )
Time frame: 18 months
To detect if the degree of hearing loss symptoms in (decibel) affect final hearing assessed by audiogram pre and post treatmentprognosis ( in s assessed by audiogram pre and post treatment
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis
Time frame: 18 months
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis ( in decibel) assessed by audiogram pre and post treatment
2 secondary outcomes
To detect if the age in years affect the final hearing prognosis
Time frame: 18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis
Time frame: 18 months
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 8 Nov 2021.
- Background: PubMed 20362815Schreiber BE, Agrup C, Haskard DO, Luxon LM. Sudden sensorineural hearing loss. Lancet. 2010 Apr 3;375(9721):1203-11. doi: 10.1016/S0140-6736(09)62071-7.
- Results publication: PubMed 22383545Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ; American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar;146(3 Suppl):S1-35. doi: 10.1177/0194599812436449.
- Results publication: PubMed 16462137Lin HC, Lee HC, Chao PZ, Wu CS. The effects of weather on the incidence of sudden sensorineural hearing loss: a 5-year population-based study. Audiol Neurootol. 2006;11(3):165-71. doi: 10.1159/000091268. Epub 2006 Feb 1.
- Results publication: PubMed 6325838Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
- Results publication: PubMed 23818120Wei BP, Stathopoulos D, O'Leary S. Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev. 2013 Jul 2;2013(7):CD003998. doi: 10.1002/14651858.CD003998.pub3.
- Results publication: PubMed 23044978Trune DR, Canlon B. Corticosteroid therapy for hearing and balance disorders. Anat Rec (Hoboken). 2012 Nov;295(11):1928-43. doi: 10.1002/ar.22576. Epub 2012 Oct 8.
- Results publication: PubMed 11318448Lalaki P, Markou K, Tsalighopoulos MG, Daniilidis I. Transiently evoked otoacoustic emissions as a prognostic indicator in idiopathic sudden hearing loss. Scand Audiol Suppl. 2001;(52):141-5. doi: 10.1080/010503901300007344.
- Results publication: PubMed 28207624Han X, Yin X, Du X, Sun C. Combined Intratympanic and Systemic Use of Steroids as a First-Line Treatment for Sudden Sensorineural Hearing Loss: A Meta-Analysis of Randomized, Controlled Trials. Otol Neurotol. 2017 Apr;38(4):487-495. doi: 10.1097/MAO.0000000000001361.
- Results publication: PubMed 26972103Jung da J, Park JH, Jang JH, Lee KY. The efficacy of combination therapy for idiopathic sudden sensorineural hearing loss. Laryngoscope. 2016 Aug;126(8):1871-6. doi: 10.1002/lary.25751. Epub 2016 Mar 12.
- Results publication: PubMed 24232060Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol. 2013 Dec;34(9):1586-9. doi: 10.1097/MAO.0000000000000222.
- Results publication: PubMed 21221047Arslan N, Oguz H, Demirci M, Safak MA, Islam A, Kaytez SK, Samim E. Combined intratympanic and systemic use of steroids for idiopathic sudden sensorineural hearing loss. Otol Neurotol. 2011 Apr;32(3):393-7. doi: 10.1097/MAO.0b013e318206fdfa.
- Results publication: PubMed 19923807Hu A, Parnes LS. Intratympanic steroids for inner ear disorders: a review. Audiol Neurootol. 2009;14(6):373-82. doi: 10.1159/000241894. Epub 2009 Nov 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing systemic and intratympanic injection of steoid in people with Idiopathic Sudden SNHL, run by Assiut University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 8 Nov 2021. 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 Egypt. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel ) (time frame: 18months). The study lists 4 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 NCT05112354, which also lists 12 linked publications.
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 8 Nov 2021.