Listening Effort in Tinnitus Patients

Tinnitus Clinical Trial

— ALERT  

Official title:

Assessment of Listening Effort in Tinnitus Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884879
• Other study ID #: 301849
• Status: Recruiting
• Start date: April 6, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: Maastricht University Medical Center
• Contact: Max RW Scheepers, PhD
• Phone: 0031620763359
• Email: m.scheepers[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Listening Effort
• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Listening effort	Subjective listening effort as a function of the speech reception threshold (SRT)	1 day
Secondary	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
Secondary	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
Secondary	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