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Clinical Trials/NCT05884879
NCT05884879
Recruiting
Not Applicable

Assessment of Listening Effort in Tinnitus Patients

Maastricht University Medical Center1 site in 1 country80 target enrollmentApril 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Listening Effort
Sponsor
Maastricht University Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Listening effort
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2023
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Listening effort

Time Frame: 1 day

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

Secondary Outcomes

  • Listening effort predictability of tinnitus related questionnaire: TFI(1 day)
  • Listening effort predictability of tinnitus related questionnaire: TQ(1 day)
  • Listening effort predictability of tinnitus related questionnaire: HADS(1 day)

Study Sites (1)

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