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Listening Effort in Tinnitus Patients

Assessment of Listening Effort in Tinnitus Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05884879
Acronym
ALERT
Enrollment
80
Registered
2023-06-01
Start date
2023-04-06
Completion date
2024-07-31
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Listening Effort, Tinnitus

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.

Interventions

BEHAVIORALTinnitus 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.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Listening effort1 daySubjective listening effort as a function of the speech reception threshold (SRT)

Secondary

MeasureTime frameDescription
Listening effort predictability of tinnitus related questionnaire: TQ1 dayRelative 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: TFI1 dayRelative 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: HADS1 dayRelative 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)

Countries

Netherlands

Contacts

Primary ContactMax RW Scheepers, PhD
m.scheepers@mumc.nl0031620763359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026