NCT05271825

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

February 16, 2022

Last Update Submit

April 9, 2024

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Tinnitus loudness

    3 months

  • Tinnitus spectrum

    3 months

  • Visual Analog Scale - annoyance

    3 months

  • Visual Analog Scale - loudness

    3 months

Study Arms (2)

Broadband amplification

EXPERIMENTAL

broadband amplification: (125 Hz to 10 kHz)

Device: Broadband amplification from hearing aids

Band-limited amplification

PLACEBO COMPARATOR

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

Device: Band-limited amplification from hearing aids

Interventions

Broadband amplification from hearing aidsDEVICE

Amplification from 125 Hz to 10 kHz

Broadband amplification
Band-limited amplification from hearing aidsDEVICE

Amplification from 25 Hz to 3-4 kHz

Band-limited amplification

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Denmark

Kongens Lyngby, Denmark

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mie Jørgensen

    Technical University of Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 9, 2022

Study Start

May 1, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)