Trial document




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  DRKS00012664

Trial Description

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Title

Efficacy of acupuncture in the treatment of acute idiopathic hearing loss with tinnitus: a randomized,
double blind control pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The "acute idiopathic hearing loss" is a hearing loss of unexplained cause. Therapeutic treatment usually only involves treatment with cortisone. Other medicinal therapeutic approaches are scientifically controversial.
Increasingly, alternative treatment methods are being offered, but these have not been partially subject to a scientific evaluation.

Since individual treatment success lead to the assumption that certain acupuncture points are effective in the deafness and tinnitus, we want to use this study to clarify the extent to which acupuncture treatment is suitable to effectively treat the symptoms of acute hearing loss with tinnitus.

In order to achieve the highest possible scientific significance of the study, there are a total of three groups in this study. One group receives an acupuncture treatment with a diagnosis of the corresponding effective point combination. A second group receives acupuncture with a diagnosis according to ineffective point combination. The third group records patients who do not receive acupuncture after cortisone therapy.
The assignment to the respective group takes place according to the random principle

The hearing performance is measured by means of a hearing test. Within the scope of the hearing test, a covert measurement is also carried out in order to better classify tinnitus, a so-called tinnitus masking. In addition, the perceived impairment by the symptoms of hearing loss and tinnitus is evaluated on a visual scale as well as questionnaires.

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Brief Summary in Scientific Language

Ethics committee Heidelberg
Study S-198/2017

Aims of the study:
Comparison of the effect of verum, control acupuncture and drug therapy in acute idiopathic hearing loss with tinnitus

Design:
Prospective, randomized, double-blind (patient- and examiner-blinded), 3-arm clinical study in a parallel-group comparison.

Main criterion: Changes in the subjectively perceived total impairment by the symptoms of tinnitus and hearing loss by means of the visual analogue scale (VAS).

Secondary Criteria: Changes of the frequency-dependent auditory sensation are measurable by means of a tone audit. The frequency and pitch is determined with a tinnitus masking. A subjective assessment of the impairment of the quality of life is recorded with the Tinnitus Handycap Inventory Questionnaire (THI). The influencing of behavior is recorded in the tinnitus questionnaire according to Goebel and Hiller (TF). The Patient Health Questionnaire (PHQ-9) examines the depression value.

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Organizational Data

  •   DRKS00012664
  •   2017/06/29
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  •   yes
  •   Approved
  •   S-198/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   H93.1 -  Tinnitus
  •   H91.2 -  Sudden idiopathic hearing loss
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Interventions/Observational Groups

  •   14 days therapy with Prednisolone in descending dosage according to guideline.
    Day 1-3: each 250mg Prednisolone
    Day 4: 100mg Prednisolone
    Day 5: 75mg Prednisolone
    Day 6: 50mg Prednisolone
    Day 7: 40mg Prednisolone
    Day 8: 20mg Prednisolone
    Day 9: 15mg Prednisolone
    Day 10: 15mg Prednisolone
    Day 11: 10mg Prednisolone
    Day 12: 10mg Prednisolone
    Day 13: 5mg Prednisolone
    Day 14: 5mg Prednisolone

    Afterwards in case of persistent symptoms 4x verum acupuncture within 14 days.
  •   14 days therapy with Prednisolone in descending dosage according to guideline.
    Day 1-3: each 250mg Prednisolone
    Day 4: 100mg Prednisolone
    Day 5: 75mg Prednisolone
    Day 6: 50mg Prednisolone
    Day 7: 40mg Prednisolone
    Day 8: 20mg Prednisolone
    Day 9: 15mg Prednisolone
    Day 10: 15mg Prednisolone
    Day 11: 10mg Prednisolone
    Day 12: 10mg Prednisolone
    Day 13: 5mg Prednisolone
    Day 14: 5mg Prednisolone

    Afterwards in case of persistent symptoms 4x placebo acupuncture within 14 days.
  •   14 days therapy with Prednisolone in descending dosage according to guideline.
    Day 1-3: each 250mg Prednisolone
    Day 4: 100mg Prednisolone
    Day 5: 75mg Prednisolone
    Day 6: 50mg Prednisolone
    Day 7: 40mg Prednisolone
    Day 8: 20mg Prednisolone
    Day 9: 15mg Prednisolone
    Day 10: 15mg Prednisolone
    Day 11: 10mg Prednisolone
    Day 12: 10mg Prednisolone
    Day 13: 5mg Prednisolone
    Day 14: 5mg Prednisolone

    Afterwards no further therapy.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Changes in the subjectively perceived overall impairment by the symptoms of tinnitus and hearing loss by means of the visual analogue scale (VAS).
Test are performed:
at initial presentation, after 14 days of therapy with Prednisolone (2 weeks after initial presentation), after acupuncture (4 weeks after initial presentation), at time of follow-up examination 8 weeks after initial presentation.

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Secondary Outcome

The hearing is to be examined in the secondary objective criterion as a change of the frequency-dependent hearing sensitivity based on the measurement by a sound auditory and the frequency of the ear noise by tinnitus masking.

With the aid of the PHQ-9 questionnaire, the patients are examined for depression, and one of the nine DSM-IV criteria (classification system for the detection of mental disorders) is recorded with each question for the diagnosis of "major depression". Hearing loss and tinnitus are often associated with psychiatric comorbidity, so that the interrelationship or their change in the course of the study can be documented.

The international Tinnitus Handycap Inventory Questionnaire (THI) in its German version also represents the impairment of the quality of life in the sense of a self-assessment instrument. In the Tinnitus questionnaire according to Goebel and Hiller (TF), the influencing of behaviors and attitudes by the complaints is depicted and he Is used to measure the subjective severity of tinnitus.

Questionnaires will be completed:
at initial presentation, after 14 days of therapy with Prednisolone (2 weeks after initial presentation), after acupuncture (4 weeks after initial presentation), at time of follow-up examination 8 weeks after initial presentation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2017/07/01
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Acute idiopathic hearing loss with tinnitus
- Written declaration of consent
- Knowledge of the German language
- Age at least 18 years
- initial, planned or ongoing, therapy with cortisone according to the standard of the ENT clinic Heidelberg

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Exclusion Criteria

- Chronic recurrent hearing loss
- Chronic tinnitus
- Known coagulopathy or anticoagulant therapy with bleeding time over 4 minutes, thrombocytes <50,000 / μl
- Lack of compliance
- Acute disease in the acupuncture area, which do not allow acupuncture
- Acute neuropsychiatric disorders
- analgesic, opioid or drug dependence
- Inability to follow the instructions in the study (lack of language, dementia)
- Participate in another clinical trial
- Continuous pension-related compensation or opposition proceedings
- Specific immunotherapy (in treatment)
- pregnancy
- Malignomas in the anamnesis
- Cortisone therapy before the beginning of the study (due to other diseases)
- nickel allergy
- silicone allergy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HNO Klinik Heidelberg
    • Mr.  Prof. Dr.  Serkan  Sertel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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    • HNO Klinik Heidelberg
    • Mr.  Prof. Dr.  Serkan  Sertel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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    • HNO Uniklinik Heidelberg
    • Mr.  Prof. Dr.   Serkan  Sertel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • HNO Klinik Heidelberg
    • Mr.  Prof. Dr.  Serkan  Sertel 
    • INF 400
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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