TinnitusNoA-TinNCT02408575
Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus
A study testing Notched filtering (verum) in people with Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Notched filtering (verum)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Regensburg - Dept of Psychiatry and ENT Dept.
Regensburg, 93053
About this study
Official title: Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
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.
- Conditions
- Tinnitus
- Being tested
- Notched filtering (verum), No filtering (placebo)
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: No filtering (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Secondary outcomes (36)
Adverse events
Measured: Week 2
Adverse events
Measured: Week 4
Adverse events
Measured: Week 8
Adverse events
Measured: Week 12
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Measured: Week 12
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Change in quality of life as measured by the WHOQoL questionnaire
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 2
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 4
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 8
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Reduction in the sumscore means improvement of tinnitus
Measured: Week 12
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Measured: Week 2
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Measured: Week 4
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Measured: Week 8
Changes in psychoacoustic tinnitus characteristics
frequency, loudness, minimal masking level
Measured: Week 12
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 8
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, M.D., Ph.D., Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408575
- Sponsor's protocol ID
- Uni-Reg-NoA-Tin
- Acronym
- NoA-Tin
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus - A Controlled Randomized Pilot Study on Safety, Tolerability and Clinical Performance
- ClinicalTrials.gov ID
- NCT02408575
- Acronym / sponsor ID
- NoA-Tin / Uni-Reg-NoA-Tin
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Notched filtering (verum) | Experimental | Device: 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 |
| No filtering (placebo) | Experimental | Device: 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Notched filtering (verum) |
| No filtering (placebo)Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 No notched filtering | Device | No filtering (placebo) |
Primary outcome
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller)
Time frame: Week 12
Reduction in the sumscore means improvement of tinnitus
36 secondary outcomes
Adverse events
Time frame: Week 2
Adverse events
Time frame: Week 4
Adverse events
Time frame: Week 8
Adverse events
Time frame: Week 12
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time frame: Week 2
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time frame: Week 4
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time frame: Week 8
Improvement of tinnitus measured by changes in the Tinnitus Questionnaire (TQ of Goebel&Hiller)
Time frame: Week 12
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Time frame: Week 2
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Time frame: Week 4
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Time frame: Week 8
Changes of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI of Newman et al 1996)
Time frame: Week 12
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Time frame: Week 2
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Time frame: Week 4
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Time frame: Week 8
Improvement of tinnitus as measured by changes in the Tinnitus Impairment Questionnaire (TBF 12)
Time frame: Week 12
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Time frame: Week 2
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Time frame: Week 4
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Time frame: Week 8
Improvement of tinnitus as measured by changes in the Clinical Global Impression questionnaire (CGI)
Time frame: Week 12
Change in quality of life as measured by the WHOQoL questionnaire
Time frame: Week 2
Change in quality of life as measured by the WHOQoL questionnaire
Time frame: Week 4
Change in quality of life as measured by the WHOQoL questionnaire
Time frame: Week 8
Change in quality of life as measured by the WHOQoL questionnaire
Time frame: Week 12
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Time frame: Week 2
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Time frame: Week 4
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Time frame: Week 8
Changes of tinnitus characteristics as measured by numeric rating scales (Tinnitus NRS Scales)
Time frame: Week 12
Changes in psychoacoustic tinnitus characteristics
Time frame: Week 2
Changes in psychoacoustic tinnitus characteristics
Time frame: Week 4
Changes in psychoacoustic tinnitus characteristics
Time frame: Week 8
Changes in psychoacoustic tinnitus characteristics
Time frame: Week 12
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 8
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, M.D., Ph.D. principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Notched filtering (verum) in people with Tinnitus, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Tinnitus Questionnaire (Mini-TQ12 of Göbel&Hiller) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.