Broadband Amplification as Tinnitus Treatment

NCT ID: NCT05271825

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-02-28

Brief Summary

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* 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

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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.

Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Broadband amplification

broadband amplification: (125 Hz to 10 kHz)

Group Type EXPERIMENTAL

Broadband amplification from hearing aids

Intervention Type DEVICE

Amplification from 125 Hz to 10 kHz

Band-limited amplification

band-limited amplification (125 Hz to 3-4 kHz)

Group Type PLACEBO_COMPARATOR

Band-limited amplification from hearing aids

Intervention Type DEVICE

Amplification from 25 Hz to 3-4 kHz

Interventions

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Broadband amplification from hearing aids

Amplification from 125 Hz to 10 kHz

Intervention Type DEVICE

Band-limited amplification from hearing aids

Amplification from 25 Hz to 3-4 kHz

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mie Joergensen

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mie Jørgensen

Role: PRINCIPAL_INVESTIGATOR

Technical University of Denmark

Locations

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Technical University of Denmark

Kongens Lyngby, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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766041

Identifier Type: -

Identifier Source: org_study_id

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