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Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus (NoA-Tin)

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ClinicalTrials.gov Identifier: NCT02408575
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Brief Summary:

Pilot study on safety, tolerability and clinical performance/randomized double-blind active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus Center of Regensburg and groupwise randomized. Control groups are being treated with hearing aids without notch-filter. Patients and raters are blinded, only the coworker, who is programming the hearing aids, is informed about the group assigned.

A Hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.


Condition or disease Intervention/treatment Phase
Tinnitus Device: Notched filtering (verum) Device: No filtering (placebo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Notched filtering (verum)

The Hearing aid with notched amplification filters frequencies in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.

Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3

Device: Notched filtering (verum)
Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.

Experimental: No filtering (placebo)

Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3

No notched filtering

Intervention: Device: Conventional hearing aid type Carat 7bx with M-Receiver; Adjustment by Connexx 7.3

Device: No filtering (placebo)

Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3

No notched filtering





Primary Outcome Measures :
  1. Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller) [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Week 2 ]
  2. Adverse events [ Time Frame: Week 4 ]
  3. Adverse events [ Time Frame: Week 8 ]
  4. Adverse events [ Time Frame: Week 12 ]
  5. Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  6. Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  7. Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  8. Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller) [ Time Frame: Week 12 ]
  9. Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996) [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  10. Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996) [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  11. Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996) [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  12. Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996) [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus

  13. Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  14. Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  15. Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  16. Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12) [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus

  17. Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  18. Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  19. Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  20. Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI) [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus

  21. Change in quality of life as measured by the WHOQoL questionnaire [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  22. Change in quality of life as measured by the WHOQoL questionnaire [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  23. Change in quality of life as measured by the WHOQoL questionnaire [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  24. Change in quality of life as measured by the WHOQoL questionnaire [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus

  25. Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) [ Time Frame: Week 2 ]
    Reduction in the sumscore means improvement of tinnitus

  26. Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) [ Time Frame: Week 4 ]
    Reduction in the sumscore means improvement of tinnitus

  27. Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) [ Time Frame: Week 8 ]
    Reduction in the sumscore means improvement of tinnitus

  28. Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales) [ Time Frame: Week 12 ]
    Reduction in the sumscore means improvement of tinnitus

  29. Changes in psychoacoustic tinnitus characteristics [ Time Frame: Week 2 ]
    frequency, loudness, minimal masking level

  30. Changes in psychoacoustic tinnitus characteristics [ Time Frame: Week 4 ]
    frequency, loudness, minimal masking level

  31. Changes in psychoacoustic tinnitus characteristics [ Time Frame: Week 8 ]
    frequency, loudness, minimal masking level

  32. Changes in psychoacoustic tinnitus characteristics [ Time Frame: Week 12 ]
    frequency, loudness, minimal masking level

  33. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 2 ]
  34. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 4 ]
  35. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 8 ]
  36. Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic tinnitus (≥ 6 months)
  • Score of ≥ 10 in TQ12 (Goebel und Hiller)
  • Mild to moderate hearing loss of at least 20 dB and maximum 70 dB between 250 Hz and 8 kHz
  • Tinnitus with tonal character or narrow band noise (< 1 oktave bandwidth)
  • Tinnitus frequency ≤ 8 kHz in tinnitus matching
  • Written informed consent of the proband
  • If therapy with psychoactive substances is necessary, it has to be stable during at least 10 days and should remain constant during study (changes will be documented in the CRF)
  • No regular use (8 hours daily) of hearing aids during 3 month before start of study

Exclusion Criteria:

  • Objective Tinnitus
  • Start of other tinnitus therapies during 3 months before start of study.
  • Missing written consent
  • Clinically relevant serious internal, neurologic or psychiatric diseases
  • Abuse of drugs, medicaments and alcohol up to 12 weeks before start of study
  • Other circumstances that object to study inclusion according to the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408575


Locations
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Germany
University of Regensburg - Dept of Psychiatry and ENT Dept.
Regensburg, Germany, 93053
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Berthold Langguth, M.D., Ph.D. University of Regensburg
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Responsible Party: Berthold Langguth, MD, Ph.D., Head of Outpatient Clinic, University of Regensburg
ClinicalTrials.gov Identifier: NCT02408575    
Other Study ID Numbers: Uni-Reg-NoA-Tin
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases