Trial document




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  DRKS00010738

Trial Description

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Title

Efficacy and safety of high dose glucocorticosteroid treatment for
idiopathic sudden sensorineural hearing loss

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Trial Acronym

HODOKORT

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URL of the Trial

http://hodokort-studie.hno.org/

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Brief Summary in Lay Language

According to recent studies, in Germany the annually cases of sudden idiopathic sensorineural hearing loss has been estimated to be 160 to 400 per 100.000. Idiopathic sudden sensorineural hearing loss (ISSHL) is one of the most frequent causes of sensorineural hearing loss. Although sensorineural hearing impairment can be partially compensated by hearing aids (HA) or cochlear implants (CI), hearing without these aids is better with respect to sound quality and communication ability. In addition, tremendous costs for society are associated with communication disorders in general and with both aids, specifically. Systemic steroids are widely used worldwide as standard of care for primary therapy of ISSHL. However, scientific data did not demonstrate a clear efficacy of any of these therapies. The German ISSHL-Guideline recommends high dose steroid (250mg Prednisolone or equivalent steroid dose) for primary therapy of ISSHL, which has not been proven so far in high-quality scientific studies. This three-armed trial is aimed to compare standard dose with two types of high-dose steroids for systemic therapy with respect to their efficacy in improving hearing, and thus communication ability in patients with idiopathic sudden sensorineural hearing loss. It is to be tested, if high-dose treatments show superiority as compared to standard treatment.
In the course of a protocol amendment, the following changes were made in October 2017: - adjustment or clarification of the inclusion / exclusion criteria. The amendment was approved by the ethics committee of the Medical Faculty of the Martin-Luther-University Halle Wittenberg on 05.10.2017.

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Brief Summary in Scientific Language

According to recent studies, in Germany the incidence of sudden idiopathic sensorineural hearing loss has been estimated to be 160 to 400 per 100.000. Idiopathic sudden sensorineural hearing loss (ISSHL) is one of the most frequent causes of sensorineural hearing loss. Although sensorineural hearing impairment can be partially compensated by hearing aids (HA) or cochlear implants (CI), generic hearing is better with respect to sound quality and communication ability. In addition, tremendous costs for society are associated with communication disorders in general and with both, HAs and CI, specifically. Systemic steroids are widely used worldwide as standard of care for primary therapy of ISSHL. However, their assessment in reviews, meta-analysis and RCTs did not demonstrate a clear efficacy of any of these therapies. The German ISSHL-Guideline recommends high dose steroid (250mg Prednisolone or equivalent steroid dose) for primary therapy of ISSHL, which has not been proven so far in RCTs. The rationale for the treatment of ISSHL using high dose steroids is only based on retrospective cohort studies. This three-armed trial is aimed to compare standard dose with two types of high-dose steroids for systemic therapy with respect to their efficacy in improving hearing, and thus communication ability in patients with idiopathic sudden sensorineural hearing loss.

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Organizational Data

  •   DRKS00010738
  •   2016/07/15
  •   [---]*
  •   yes
  •   Approved
  •   2016-33, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  •   2015-002602-36 
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Health Condition or Problem studied

  •   H91 -  Other hearing loss
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Interventions/Observational Groups

  •   Prednisolone, 250 mg/day i.v., for 5 days (+ Placebo p.o. 10 days)
  •   Dexamethasone, 40 mg/day p.o., for 5 days (+ Placebo i.v. 5 days/ p.o. 5 days)
  •   Prednisolone, 60 mg/day p.o., für 5 days & Prednisolone in tapering doses (2 x 40 mg and 3 x 20 mg), for 5 days (+ Placebo i.v. in the first 5 days)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
  •   Yes
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Primary Outcome

Average change in hearing thresholds (pure-tone average of the 3 most affected contiguous frequencies)

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Secondary Outcome

-average change in pure tone hearing level (3PTA0,5-2kHz [Fletcher- Typ] und 4PTA0,5-4kHz) 30 days after enrolment
-percentage of patients with complete, partial or no improvement of hearing
-average change in percentage of ear-specific masked monosyllabic words understood correctly at 65 and 80 dB SPL
-patient self evaluation, quality of life and communication competence (patient questionnaires SF-12, HHIE)
-percentage of patients needing a hearing aid/ cochlear implant
-percentage of patients with new or worsened arterial hypertension at day 5 (office blood pressure >140 mmHg syst. or >90 mmHg diast. or both)
-percentage of patients with altered glucose tolerance at day 5 (to be detected by HOMA-IR)
-need for rescue therapy
-occurrence and extent of tinnitus one and six month after enrolment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/11/28
  •   312
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

-female and male adults (18-80 years)
-unilateral sensorineural hearing loss
-sudden onset of hearing loss (occurring within 24 hours)
-unknown etiology (no other ear or CNS disease)
-change in hearing threshold due to ISSHL of 30 dB or higher compared to a pre-event audiogram, the audiogram of the unaffected ear, or the ISO) for the 3 most affected contiguous frequencies in the affected ear but not less then 50 dB absolute threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz
-enrolment and treatment within 7 days from onset

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Exclusion Criteria

-recurrent ISSHL at the affected side (< 12 months)
-known other otologic cause of ISSHL (e.g.: middle ear disease; vestibular schwannoma; known fluctuating hearing loss; Meniere’s disease)
-absolute hearing threshold as average of the 3 most affected contiguous frequencies between 0,25 und 8 kHz < 50 dB HL
-certain systemic diseases (treatment for or chronically active infection such as HIV, hepatitis C or B, tuberculosis, hard to balance diabetes mellitus, ongoing immunosuppressive treatment for rheumatic or chronic inflammatory disease, unstable atherosclerotic disease, heart failure >NYHA II, suicidality, severe osteoporosis, active peptic ulcer, uncontrolled (syst. >180 mmHg or diast. >100 mmHg) arterial hypertension)
-treated mental disorders or after surgical interventions in the last 6 weeks: inclusion only after critical evaluation by the investigator
-pre-treatment of ISSHL with glucocorticosteroids or hyperbaric oxygen
-conductive deafness (air-bone gap 4PTA0,5-4kHz >10 dB)
-pregnancy or lactation

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Addresses

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    • Martin-Luther-Universität Halle-Wittenberg
    • 06097  Halle (Saale)
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Prof.  Stefan  Plontke 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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    • Universitätsklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie oder Prüfärzte am jeweiligen Standort,
    • Mr.  Prof.  Stefan  Plontke 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.