Trial document




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  DRKS00013454

Trial Description

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Title

MusiCI - Music Therapy in Early Rehabiliation after Cochlear Implantation - impact on speech comprehension

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Trial Acronym

MusiCI

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URL of the Trial

http://www.dzm-heidelberg.de/forschung/aktuelle-projekte/

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Brief Summary in Lay Language

Since 2014 at the ENT-clinic of the Heidelberg University Hospital in cooperation with the DZM e.V. (Deutsches Zentrum für Musiktherapieforschung, German Center for Music Therapy Research), Heidelberg an evidence based music therapy training has offered as part of the outpatient rehabilitation program for adult cochlear implant (CI) recipients
The aim of this individualized music based training is to promote both auditory and language perception. Participants restore confidence in their auditory perception, experience their own voice and the prosodic elements of speech (i.e. speech melody, vocal intonation) and learn to discriminate speech, sounds, tones and noises via the CI.
Results from previous trials prove the positive outcome of the Heidelberg Music Therapy Model in general auditory performance and more specifically the perception of musical elements. To date, there are no scientific findings concerning the cross-modal benefits of the Heidelberg Music Therapy on linguistic abilities.
The aim of the current trial – supported by MED-EL Germany – is to investigate the effectiveness of music therapy regarding the speech comprehension during the early stages of rehabilitation after cochlear implantation, i.e. during the first year (months 0-12) after initial fitting of the speech processor.
Late-deafened adults (i.e. patients suffering from a deafness which developed after the acquisition of speech and language, so called post-lingual deafness) who are provided with their first CI are eligible for this trial. Three different conditions will be compared, patients are randomly allocated to one of these three groups. All patients receive the standard CI-rehabilitation program offered by the university ENT-clinic Heidelberg (CI speech processor fittings, auditory training, and group counselling, medical consultations). Patients allocated to group C do not receive any further treatment. For patients allocated groups A and B a specific music therapy training is proposed – either focusing on linguistic perception (group A) or on global auditory perception (group B). Patients allocated to group C might attend music therapy during their second year of rehabilitation.
Music therapy sessions start about three months after the initial fitting of the speech processor and consists of six 50-minute sessions of individualized music therapy. The music therapy sessions will take part at the DZM e.V.; Heidelberg. Prior musical knowledge is not necessary.
Three, six and twelve months after the initial fitting of the speech processor, all patients undergo three standardized diagnostic examinations, assessing linguistic, audiometric, psychologic and music related perceptual abilities.
Patients attending a music therapy training are likely to be more satisfied with the subjective hearing quality compared patients of the control group. Concerning the specialized treatments, we expect distinct effects: the linguistic training is supposed to foster prosody (speech melody and intonation) and speech comprehension particularly while auditory training probably promotes hearing abilities in everyday situations (e.g. sounds, directional hearing).

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Brief Summary in Scientific Language

Postlingually deaf adults provided with a cochlear implant usually achieve good speech comprehension in silent surroundings. More complex hearing tasks such as speech comprehension in background noise or perception of prosody are far more demanding. At the ENT-clinic of the Heidelberg University Hospital all adult CI users are routinely enrolled in a focused postoperative rehabilitation program lasting for two years. This program includes fitting of the sound processor, medical aftercare, audiological assessments, audiological therapy, hearing training, and group counseling sessions – and music therapy! An ongoing individual music therapy as regular part of the early rehabilitation program for adult CI recipients is unique in Germany.
Study results indicate a significant increase in hearing quality (HISQUI), and in musical hearing performance (i.e. pitch discrimination, melody recognition and timbre identification as well as prosodic elements in speech).
The current trial aims at a specification of the therapy concept regarding the individual needs of the patients.
Postlingually deaf CI-users will be traced during their first year of rehabilitation. All patients receive the standard care according to the Heidelberg rehabilitation program. During the first twelve months, two groups of patients additionally receive six 50-minute sessions of individualized music therapy. In one group (group A), the music therapy is focusing on prosodic features (group A), in the other group (group B) the music therapy is focusing on auditory rehabilitation (music perception and acceptance of the CI). A third group (group C) consist of patients on a waiting list without any specific music based training. There are three standardized times of measurement: baseline-measurement 3 months after the initial activation of the CI speech processor, intermediate measurement after 6 months and final measurement after 12 months. Main objectives are evaluation of hearing performance (pure-tone audiometry, speech in noise tests as well as tests on prosody (PC-based test ProsA), musical accuracy and appraisal of subjective hearing level (Hearing Implant Sound Quality Index, HISQUI). Secondary objectives are quality of life and music listening habits and musical appraisal (assessed by Munich Music questionnaire MUMU). This schedule allows for longitudinal and cross-sectional comparison of differential music based procedures in aural rehabilitation during the first 12 months of rehabilitation.
Patients attending a music therapy training are likely to be more satisfied with the subjective hearing quality compared patients of the control group. Concerning the specialized treatments, we expect distinct effects: the linguistic training is supposed to foster prosody and speech comprehension particularly while auditory training probably promotes hearing abilities in everyday situations (e.g. sounds, directional hearing).

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Organizational Data

  •   DRKS00013454
  •   2017/12/05
  •   [---]*
  •   yes
  •   Approved
  •   S-567/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z96.2 -  Presence of otological and audiological implants
  •   Early Rehabilitation following cochlear implantation - impact of music therapy
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Interventions/Observational Groups

  •   Music Therapy, main focus on prosody
    (6 session individual music therapy à 50 minutes, during the time period 3-6 months after the initial activation of the speech processor);
    Standard care in early rehabilitation (overall 16 "reha-days" during the first 12 months; contents are: fitting of the speech processor, auditory training, audiotherapy, group counseling, medical care)
  •   Music Therapy, main focus on auditory rehabilitation (music perception and appraisal of CI)
    (6 session individual music therapy à 50 minutes, during the time period 3-6 months after the initial activation of the speech processor);
    Standard care in early rehabilitation (overall 16 "reha-days" during the first 12 months; contents are: fitting of the speech processor, auditory training, audiotherapy, group counseling, medical care)
  •   waiting list control group without specific music therapy but standard care in early rehabilitation (overall 16 "reha-days" during the first 12 months; contents are: fitting of the speech processor, auditory training, audiotherapy, group counseling, medical care)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Main objectives are evaluation of hearing performance assessed by both objective tests (pure-tone audiometry, speech in noise tests, PC-based test on prosody ProsA), musical accuracy) and validated questionnaires (Hearing Implant Sound Quality Index, HISQUI) at three measurement times (3, 6, 12 months after initial activation of the speech processor)

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Secondary Outcome

NCIQ ((Nijmegen Cochlear Implantation Questionnaire): Subjective quality of life
MUMU (Munich Music questionnaire): Music listening habits and musical appraisal at three measurement times (3, 6, 12 months after initial activation of the speech processor)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2017/12/01
  •   60
  •   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

• Postlinguale deafness
• native speaker competence in German language
• unilateral cochlear implant (any commonly used device with medical certification, independent from manufacturer)
• age ≥ 18 years
• Surgery, initial fitting of the speech processor and early rehabiliation at the ENT-clinic of the Heidelberg University Hospital

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Exclusion Criteria

• prelingual or congenital deafness
• bilateral cochlear implant
• clinical diagnosis of a serious mental, neurological or psychiatric disease (e.g. psychosis, epilepsy, Parkinson’s disease, dementia, drug or alcohol addiction)
• status post traumatic brain injury or cerebral ischemia
• psychotropic medication that cannot be discontinued before the cochlear implantation
• Inability to speak, read and/or comprehend German language
• Inability to give written consent

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Addresses

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    • Deutsches Zentrum für Musiktherapieforschung DZM e.V.
    • Maaßstr. 26
    • 69123  Heidelberg
    • Germany
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    • Deutsches Zentrum für Musiktherapieforschung DZM e.V.
    • Ms.  Dr.  Heike  Argstatter 
    • Maaßstr. 26
    • 69123  Heidelberg
    • Germany
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    • Hals-Nasen-Ohrenklinik Universität HeidelbergSektion Otologie und Neuro-OtologieCiRZ Heidelberg (Cochlea-Implantat Rehazentrum Heidelberg)
    • Mr.  Prof. Dr.  Mark  Praetorius 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Deutsches Zentrum für Musiktherapieforschung DZM e.V.
    • Ms.  Dr.  Heike  Argstatter 
    • Maaßstr. 26
    • 69123  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • MED-EL Deutschland
    • Mr.  Dr.  Hansjörg  Schösser 
    • Moosstraße 7 / 2. OG
    • 82319  Starnberg
    • 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.