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Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

2021年10月31日 更新者:suhaib abdelzaker Mohamed、Assiut University

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

  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.

調査の概要

詳細な説明

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

  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 .

研究の種類

介入

入学 (実際)

40

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年~90年 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient below 6 years old

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

-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.

他の名前:
  • Microscopic Intratympanic steroid injection

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel )
時間枠: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
18months
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases and chronic kidney disease ) affect the final hearing prognosis in decibel
時間枠: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
18months
To detect if the severity of hearing loss symptoms in (decibel ) affect final hearing prognosis ( in decibel )
時間枠: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
18 months
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis
時間枠: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
18 months

二次結果の測定

結果測定
メジャーの説明
時間枠
To detect if the age in years affect the final hearing prognosis
時間枠:18 months
To detect if the age in years affect the final hearing prognosis assessed by audiogram pre and post treatment
18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis
時間枠:18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis assessed by pre and post treatment audiogram
18 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年12月1日

一次修了 (実際)

2021年6月1日

研究の完了 (実際)

2021年6月30日

試験登録日

最初に提出

2019年9月24日

QC基準を満たした最初の提出物

2021年10月31日

最初の投稿 (実際)

2021年11月8日

学習記録の更新

投稿された最後の更新 (実際)

2021年11月8日

QC基準を満たした最後の更新が送信されました

2021年10月31日

最終確認日

2021年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Predictive factors in ISSNHL

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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