ALERT: Listening Effort in Tinnitus Patients

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05884879
Collaborator
(none)
80
1
15.8
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tinnitus simulation

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Listening Effort in Tinnitus Patients
Actual Study Start Date :
Apr 6, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Tinnitus group

Young adults, i.e. 18-40 year old; Hearing thresholds better than 30 dB Hearing Level (HL) at all octave frequencies 0.25-8.0 kilohertz (kHz); Proficient and native speaker of Dutch language; Severe unilateral or bilateral tinnitus disorder (TQ > 46).

Control group

Young adults, i.e. 18-40 year old; Hearing thresholds better than 30 dB HL at all octave frequencies 0.25-8.0 kHz; Proficient and native speaker of Dutch language; No tinnitus.

Behavioral: Tinnitus simulation
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.

Outcome Measures

Primary Outcome Measures

  1. Listening effort [1 day]

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

Secondary Outcome Measures

  1. Listening effort predictability of tinnitus related questionnaire: TQ [1 day]

    Relative importance of sub scales of tinnitus related questionnaires for predicting the amount of listening effort in tinnitus patients: Tinnitus Questionnaire (score 0-84, higher score = more tinnitus disorder)

  2. Listening effort predictability of tinnitus related questionnaire: TFI [1 day]

    Relative importance of sub scales of tinnitus related questionnaires for predicting the amount of listening effort in tinnitus patients: Tinnitus Functional Index (score 0-100, higher score = more negative impact of tinnitus)

  3. Listening effort predictability of tinnitus related questionnaire: HADS [1 day]

    Relative importance of sub scales of tinnitus related questionnaires for predicting the amount of listening effort in tinnitus patients: Hospital Anxiety and Depression Scale (score 0-21, higher score = more anxiety and/or depression)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Young adults, i.e. 18-40 year old;

  • Hearing thresholds better than 30 dB HL at all octave frequencies 0.25-8.0 kHz;

  • Proficient and native speaker of Dutch language;

  • TINNITUS GROUP: Severe unilateral or bilateral tinnitus disorder (TQ > 46).

  • CONTROL GROUP: No tinnitus.

Exclusion Criteria:
  • Significant asymmetric hearing loss: |PTAright - PTAleft| > 8 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht UMC+ Maastricht Limburg Netherlands 6229 HX

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

  • Principal Investigator: Erwin LJ George, MPE PhD, Maastricht UMC+

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT05884879
Other Study ID Numbers:
  • 301849
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023