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Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

Primary Purpose

Idiopathic Sudden SNHL

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
systemic and intratympanic injection of steoid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Sudden SNHL

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All cases above 6 years presented with unilateral or bilateral ISSNHL

Exclusion Criteria:

  • Patient below 6 years old

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the main group

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
September 24, 2019
Last Updated
October 31, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05112354
Brief Title
Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss
Official Title
Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Sudden SNHL

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Masking Description
both the invistigator and care provider donot know the detailes of audiological evalution of the patient nor the comobidities of the patient
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the main group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
systemic and intratympanic injection of steoid
Other Intervention Name(s)
Microscopic Intratympanic steroid injection
Intervention 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.
Primary Outcome Measure Information:
Title
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel )
Description
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
Time Frame
18months
Title
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases and chronic kidney disease ) affect the final hearing prognosis in decibel
Description
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
Time Frame
18months
Title
To detect if the severity of hearing loss symptoms in (decibel ) affect final hearing prognosis ( in decibel )
Description
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
Time Frame
18 months
Title
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To detect if the age in years affect the final hearing prognosis
Description
To detect if the age in years affect the final hearing prognosis assessed by audiogram pre and post treatment
Time Frame
18 months
Title
to detect if unilateral or bilateral symptoms affect the final hearing prognosis
Description
to detect if unilateral or bilateral symptoms affect the final hearing prognosis assessed by pre and post treatment audiogram
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All cases above 6 years presented with unilateral or bilateral ISSNHL Exclusion Criteria: Patient below 6 years old
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20362815
Citation
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.
Results Reference
background
PubMed Identifier
22383545
Citation
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.
Results Reference
result
PubMed Identifier
16462137
Citation
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.
Results Reference
result
PubMed Identifier
6325838
Citation
Byl FM Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope. 1984 May;94(5 Pt 1):647-61.
Results Reference
result
PubMed Identifier
23818120
Citation
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.
Results Reference
result
PubMed Identifier
23044978
Citation
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.
Results Reference
result
PubMed Identifier
11318448
Citation
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.
Results Reference
result
PubMed Identifier
28207624
Citation
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.
Results Reference
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PubMed Identifier
26972103
Citation
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.
Results Reference
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PubMed Identifier
24232060
Citation
Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol. 2013 Dec;34(9):1586-9. doi: 10.1097/MAO.0000000000000222.
Results Reference
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PubMed Identifier
21221047
Citation
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.
Results Reference
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PubMed Identifier
19923807
Citation
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.
Results Reference
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Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

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