Broadband Amplification as Tinnitus Treatment

Tinnitus, Subjective Clinical Trial

Official title:

Broadband Amplification as Tinnitus Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271825
• Other study ID #: 766041
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2024
• Source: Technical University of Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Device:
• Broadband amplification from hearing aids
Amplification from 125 Hz to 10 kHz
• Band-limited amplification from hearing aids
Amplification from 25 Hz to 3-4 kHz

Locations

Country	Name	City	State
Denmark	Technical University of Denmark	Kongens Lyngby

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory	Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)	3 months
Primary	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	3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	Visual Analog Scale - annoyance	Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying"	3 months
Secondary	Visual Analog Scale - loudness	Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud"	3 months