Listening EffortALERTNCT05884879
Listening Effort in Tinnitus Patients
An observational study of Listening Effort and Tinnitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Listening Effort, Tinnitus
- What is being tested?
- Tinnitus simulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Apr 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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+.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6229 HX
About this study
Official title: 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.
- Conditions
- Listening Effort, Tinnitus
- Being tested
- Tinnitus simulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus simulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tinnitus simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listening effort
Subjective listening effort as a function of the speech reception threshold (SRT)
Measured: 1 day
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start6 Apr 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Listening EffortStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwin LJ George, MPE PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884879
- Sponsor's protocol ID
- 301849
- Acronym
- ALERT
- Status last verified
- May 2023
- First submitted
- 28 Apr 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Listening Effort in Tinnitus Patients
- ClinicalTrials.gov ID
- NCT05884879
- Acronym / sponsor ID
- ALERT / 301849
- Conditions
- Listening Effort, Tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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+.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus simulationThe 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. | Behavioural | Control group |
Primary outcome
Listening effort
Time frame: 1 day
Subjective listening effort as a function of the speech reception threshold (SRT)
3 secondary outcomes
Listening effort predictability of tinnitus related questionnaire: TQ
Time frame: 1 day
Listening effort predictability of tinnitus related questionnaire: TFI
Time frame: 1 day
Listening effort predictability of tinnitus related questionnaire: HADS
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin LJ George, MPE PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Listening Effort and Tinnitus, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max RW Scheepers, PhD (0031620763359, m.scheepers@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening effort (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.