Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss
NCT ID: NCT05112354
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2019-12-01
2021-06-30
Brief Summary
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Aim of work
1. To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL
2. To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.
Detailed Description
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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
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.
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
1. Age.
2. Onset of the disease.
3. . tinnitus.
4. vertigo.
5. audiogram to detect the degree of hearing loss mild,moderate severe profund .speech discrimition low frequencies versus high frequencies.
6. Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
7. 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
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Study Design
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NA
SINGLE_GROUP
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.
OTHER
NONE
Study Groups
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the main group
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
systemic and intratympanic injection of steoid
-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.
Interventions
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systemic and intratympanic injection of steoid
-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
90 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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suhaib abdelzaker Mohamed
Resident doctor in otolaryngology
Locations
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Assiut university
Asyut, , Egypt
Countries
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References
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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.
Stachler 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.
Lin 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.
Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
Wei 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.
Trune 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.
Lalaki 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.
Han 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.
Jung 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.
Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol. 2013 Dec;34(9):1586-9. doi: 10.1097/MAO.0000000000000222.
Arslan 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.
Hu 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.
Other Identifiers
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Predictive factors in ISSNHL
Identifier Type: -
Identifier Source: org_study_id