Listening Effort in Tinnitus Patients (ALERT)

Assessment of Listening Effort in Tinnitus Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Tinnitus; Listening Effort
• Intervention / Treatment: Behavioral: Tinnitus simulation

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Max RW Scheepers, PhD; Phone Number: 0031620763359; Email: m.scheepers@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht UMC+

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

TINNITUS GROUP:

Tinnitus patients visiting the Audiological Centre of Maastricht UMC+, Adelante Zorggroep Hoensbroek and Blerick, Libra Eindhoven, Kentalis Eindhoven, Den Bosch and Nijmegen.

CONTROL GROUP:

General population visiting the Maastricht UMC+.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listening effort	Subjective listening effort as a function of the speech reception threshold (SRT)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Listening effort predictability of tinnitus related questionnaire: TQ	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)	1 day
Listening effort predictability of tinnitus related questionnaire: TFI	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)	1 day
Listening effort predictability of tinnitus related questionnaire: HADS	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)	1 day

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Erwin LJ George, MPE PhD, Maastricht UMC+

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 301849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No