Listening Effort in Tinnitus Patients

NCT ID: NCT05884879

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2024-07-31

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.

Conditions

Listening Effort; Tinnitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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.

Tinnitus simulation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin LJ George, MPE PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC+

Locations

Maastricht UMC+

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Max RW Scheepers, PhD

Role: CONTACT

m.scheepers@mumc.nl

0031620763359

Other Identifiers

301849

Identifier Type: -

Identifier Source: org_study_id