NCT02408575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 18, 2015

Last Update Submit

October 25, 2016

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

  • Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)

    Reduction in the sumscore means improvement of tinnitus

    Week 12

Secondary Outcomes (36)

  • Adverse events

    Week 2

  • Adverse events

    Week 4

  • Adverse events

    Week 8

  • Adverse events

    Week 12

  • Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)

    Week 2

  • +31 more secondary outcomes

Study Arms (2)

Notched filtering (verum)

EXPERIMENTAL

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)

No filtering (placebo)

EXPERIMENTAL

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)

Interventions

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.

Notched filtering (verum)
No filtering (placebo)DEVICE

Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering

No filtering (placebo)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg - Dept of Psychiatry and ENT Dept.

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Berthold Langguth, M.D., Ph.D.

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Outpatient Clinic

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 3, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)