NCT05884879

Brief Summary

About 5-15% of the general population experience a chronic ringing, buzzing, hissing or roaring sound in one or two ears, without any external source. This so-called tinnitus can be present in people with normal hearing, but often coexists with hearing loss. Most people suffering from tinnitus can cope with it, however a minority experiences emotional distress or cognitive dysfunction as a result of the tinnitus, called tinnitus disorder. People suffering from tinnitus disorder regularly complain about an increased experienced effort when listening to speech or other sounds in daily life situations. As this has never been proven scientifically, the investigators aim to evaluate the effect of the tinnitus percept and tinnitus disorder on experienced listening effort by comparing listening effort between a population with tinnitus disorder and a population without tinnitus.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 6, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 22, 2024

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

April 28, 2023

Last Update Submit

March 21, 2024

Conditions

Listening EffortTinnitus

Outcome Measures

Primary Outcomes (1)

  • Listening effort

    Subjective listening effort as a function of the speech reception threshold (SRT)

    1 day

Secondary Outcomes (3)

  • Listening effort predictability of tinnitus related questionnaire: TQ

    1 day

  • Listening effort predictability of tinnitus related questionnaire: TFI

    1 day

  • Listening effort predictability of tinnitus related questionnaire: HADS

    1 day

Study Arms (2)

Tinnitus group

* Adults, i.e. 18-69 year old; * Pure tone average \<35 dB HL (0.5, 1, 2, 4 kHz); * Proficient and native speaker of Dutch language; * Severe unilateral or bilateral tinnitus disorder (TQ \> 46).

Control group

* Adults, i.e. 18-69 year old; * Pure tone average \<35 dB HL (0.5, 1, 2, 4 kHz); * Proficient and native speaker of Dutch language; * No tinnitus.

Behavioral: Tinnitus simulation

Interventions

Tinnitus simulationBEHAVIORAL

The control group will perform speech perception tests and listening effort tests in the absence and presence of a simulated tinnitus percept using a bone vibrator.

Control group

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

TINNITUS GROUP: Tinnitus patients visiting the Audiological Centre of Maastricht UMC+, Adelante Zorggroep Hoensbroek and Blerick, Libra Eindhoven, Kentalis Eindhoven, Den Bosch and Nijmegen. CONTROL GROUP: General population visiting the Maastricht UMC+.

You may qualify if:

  • Young adults, i.e. 18-69 year old;
  • Pure tone average \<35 dB HL (0.5, 1, 2, 4 kHz);
  • Proficient and native speaker of Dutch language;
  • TINNITUS GROUP: Severe unilateral or bilateral tinnitus disorder (TQ \> 46).
  • CONTROL GROUP: No tinnitus.

You may not qualify if:

  • Significant asymmetric hearing loss: \|PTAright - PTAleft\| \> 15 dB (PTA = pure tone average of 500, 1000, 2000 and 4000 Hz);
  • Significant loss of vision (text on screen at 70 cm should be readable);
  • Frequent user of any of the following devices: Hearing Aid, Bone Conduction Device, Cochlear Implant, Tinnitus Masker;
  • Additional mental or physical disabilities that may prevent active participation and testing as per protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

  • Erwin LJ George, MPE PhD

    Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Max RW Scheepers, PhD

CONTACT

0031620763359m.scheepers@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

June 1, 2023

Study Start

April 6, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

March 22, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)