Listening Effort in Tinnitus Patients

Recruiting

• Conditions: Listening Effort; Tinnitus
• Interventions: Behavioral: Tinnitus simulation

• Registration Number: NCT05884879
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Study First Submitted: 2023-04-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Tinnitus simulation	* 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.

Primary Outcome Measures

Name	Time	Method
Listening effort	1 day	Subjective listening effort as a function of the speech reception threshold (SRT)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (1)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands