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Tinnitus, SubjectiveNCT05271825

Broadband Amplification as Tinnitus Treatment

A study testing Broadband amplification from hearing aids and Band-limited amplification from hearing aids in people with Tinnitus, Subjective, run by Technical University of Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The effect of broadband amplification was tested in a double-blinded crossover study Its effect was compared to an active placebo treatment An improvement in tinnitus distress was found after use of broadband amplification No effect was found on the tinnitus loudness Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Tinnitus, Subjective
What is being tested?
Broadband amplification from hearing aids and Band-limited amplification from hearing aids
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteDenmark
Study dates
1 May 2019to 28 Feb 2021
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic tinnitus
  • hearing thresholds (<=25 dB HL) up to 2000 Hz and hearing loss at frequencies above 2 kHz
  • inexperienced hearing aid user

Who cannot join

  • objective or pulsatile tinnitus
  • Ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Technical University of Denmark

    Kongens Lyngby

Other trials in Denmark

About this study

  • The effect of broadband amplification was tested in a double-blinded crossover study
  • Its effect was compared to an active placebo treatment
  • An improvement in tinnitus distress was found after use of broadband amplification
  • No effect was found on the tinnitus loudness
Read the detailed description

This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Being tested
Broadband amplification from hearing aids, Band-limited amplification from hearing aids
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Broadband amplification from hearing aidsDevice

    Amplification from 125 Hz to 10 kHz

  • Band-limited amplification from hearing aidsDevice

    Amplification from 25 Hz to 3-4 kHz

Study groups in NCT05271825
Study groupRoleWhat they receive
Broadband amplificationExperimentalbroadband amplification: (125 Hz to 10 kHz)
Receives: Device: Broadband amplification from hearing aids
Band-limited amplificationPlacebo comparatorband-limited amplification (125 Hz to 3-4 kHz)
Receives: Device: Band-limited amplification from hearing aids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Handicap Inventory

    Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)

    Measured: 3 months

  2. Tinnitus Functional Index

    Questionnaire assessing tinnitus related distress. 25 questions that can be answered with likert scale from 0-10 (or 0-100%) where 10 is the most extreme negative value

    Measured: 3 months

Secondary outcomes (4)

  1. Tinnitus loudness

    Psychoacoustic measurement. Participants are asked to match the loudness of their tinnitus to either a pure-tone or noisy sound. The loudness of the matched tone could be changed in 3 decibel steps.

    Measured: 3 months

  2. Tinnitus spectrum

    The tinnitus spectrum rating method was adapted from Noreña et al. (2002). As the stimuli, either 2-s long pure tones (1st condition) or 2-s long 1/3-octave noise bands (2nd condition) with center frequencies ranging from 125 Hz to 14 kHz were used. The stimuli were presented monaurally via headphones to the ear corresponding to the loudest tinnitus perception. In case the tinnitus percept was the same in both ears, the stimuli were presented to the ear with the lowest average high-frequency thresholds. All stimuli were presented at the level matched to the tinnitus loudness for a 1 kHz pure tone, but always at or above 10 dB sensation level (SL).

    Measured: 3 months

  3. Visual Analog Scale - annoyance

    Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"

    Measured: 3 months

  4. Visual Analog Scale - loudness

    Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start1 May 2019
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271825
Sponsor's protocol ID
766041
Status last verified
Apr 2024
First submitted
16 Feb 2022
Last updated
10 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Broadband amplification from hearing aids and Band-limited amplification from hearing aids in people with Tinnitus, Subjective, run by Technical University of Denmark at 1 site in Denmark.

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 3 inclusion and 2 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 10 Apr 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?

Tinnitus Handicap Inventory (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05271825.

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 10 Apr 2024.

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