Broadband Amplification as Tinnitus Treatment
Primary Purpose
Tinnitus, Subjective
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Broadband amplification from hearing aids
Band-limited amplification from hearing aids
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
Eligibility Criteria
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
Sites / Locations
- Technical University of Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Broadband amplification
Band-limited amplification
Arm Description
broadband amplification: (125 Hz to 10 kHz)
band-limited amplification (125 Hz to 3-4 kHz)
Outcomes
Primary Outcome Measures
Tinnitus Handicap Inventory
Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)
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
Secondary Outcome Measures
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.
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).
Visual Analog Scale - annoyance
Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"
Visual Analog Scale - loudness
Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"
Full Information
NCT ID
NCT05271825
First Posted
February 16, 2022
Last Updated
March 9, 2022
Sponsor
Technical University of Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05271825
Brief Title
Broadband Amplification as Tinnitus Treatment
Official Title
Broadband Amplification as Tinnitus Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Broadband amplification
Arm Type
Experimental
Arm Description
broadband amplification: (125 Hz to 10 kHz)
Arm Title
Band-limited amplification
Arm Type
Placebo Comparator
Arm Description
band-limited amplification (125 Hz to 3-4 kHz)
Intervention Type
Device
Intervention Name(s)
Broadband amplification from hearing aids
Intervention Description
Amplification from 125 Hz to 10 kHz
Intervention Type
Device
Intervention Name(s)
Band-limited amplification from hearing aids
Intervention Description
Amplification from 25 Hz to 3-4 kHz
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory
Description
Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)
Time Frame
3 months
Title
Tinnitus Functional Index
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tinnitus loudness
Description
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.
Time Frame
3 months
Title
Tinnitus spectrum
Description
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).
Time Frame
3 months
Title
Visual Analog Scale - annoyance
Description
Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"
Time Frame
3 months
Title
Visual Analog Scale - loudness
Description
Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mie Jørgensen
Organizational Affiliation
Technical University of Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University of Denmark
City
Kongens Lyngby
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Broadband Amplification as Tinnitus Treatment
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