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Completed

NCT Number: NCT05271825

Broadband Amplification as Tinnitus Treatment

* 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

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Denmark

Kongens Lyngby, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Broadband amplification from hearing aids

Device

Amplification from 125 Hz to 10 kHz

Band-limited amplification from hearing aids

Device

Amplification from 25 Hz to 3-4 kHz

Primary outcomes

  1. Tinnitus Handicap Inventory

    Time frame: 3 months

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

  2. Tinnitus Functional Index

    Time frame: 3 months

    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

Secondary outcomes

  1. Tinnitus loudness

    Time frame: 3 months

    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.

  2. Tinnitus spectrum

    Time frame: 3 months

    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).

  3. Visual Analog Scale - annoyance

    Time frame: 3 months

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

  4. Visual Analog Scale - loudness

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Technical University of Denmark

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2022
Registry last updated
Apr 10, 2024

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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