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Completed

NCT Number: NCT02408575

Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg - Dept of Psychiatry and ENT Dept.

Regensburg, 93053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Notched filtering (verum)

Device

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.

No filtering (placebo)

Device

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

No notched filtering

Primary outcomes

  1. Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)

    Time frame: Week 12

    Reduction in the sumscore means improvement of tinnitus

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance

Acronym: NoA-Tin

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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