Hearing DisabilityTRAILSNCT05766020
Training Listening Skills With the Inclusion of Cognitive Control
A study testing Listen training in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Disability
- What is being tested?
- Listen training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients who experience listening and communication difficulties.
- Clients must not undergo any audiological rehabilitation (auditory training/hearing aid fitting) during the study.
- Able to operate the training programme as an app on a tablet (e.g. clients have sufficient eyesight to see the exercises; clients must be able to operate the programme).
- At least 18 years old.
- Dutch-speaking, as all training material and counselling questions will be presented in Dutch.
Who cannot join
- Severely visually impaired
- Motorically impaired
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven, Experimental ORL, Dept Neurosciences
Leuven, Vlaams Brabant, 3001
About this study
Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.
Read the detailed description
Goals of the study:
- Investigate transfer of listening skills to non-trained listening.
- To develop evidence-based guidelines for clinical audiological rehabilitation.
- Investigate if the inclusion of cognitive control frees up cognitive resources to use for another concurrent task.
- Inform about retention following listening training
All participants will be assessed 4 times, with a 4-week interval in between. Participants in the first arm will perform the training during the first two weeks. 4 weeks after training ended and 8 weeks after training ended, retention of training gains will be assessed. Participants in the second arm will perform the delayed training. This is to control for procedural learning effects. After 4 weeks they will start training for 4 weeks. After training retention of training gains will be assessed after 4 weeks. The third arm will start with active control training (listening to stories) for 4 weeks, followed by training for 4 weeks. After these 8 weeks, retention was measured 4 weeks later. Participants are randomly allocated to a group. The efficacy of training will be determined with a within-subject design (i.e. baseline session outcomes will be compared to the final session outcomes of the randomized control trial.
- Conditions
- Hearing Disability
- Being tested
- Listen training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listen trainingBehavioural
Auditory skills with the inclusion of cognitive control.
| Study group | Role | What they receive |
|---|---|---|
| Immediate training group | Experimental | Participants in this group will train immediately for 4 weeks. Afterwards, they will not train for the 8 remaining weeks. Receives: Behavioral: Listen training |
| Delayed Training Group | Experimental | Participants in this group will receive delayed training after 4 weeks of no training. Receives: Behavioral: Listen training |
| Active control group | Experimental | Participants in this group will perform an active control for 4 weeks, followed by 4 weeks of training. Receives: Behavioral: Listen training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in noise intelligibility
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Measured: 0 weeks
Speech in noise intelligibility
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Measured: 4 weeks
Speech in noise intelligibility
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Measured: 8 weeks
Speech in noise intelligibility
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Measured: 12 weeks
phoneme identification in noise
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
Measured: 0 weeks
phoneme identification in noise
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
Measured: 4 weeks
phoneme identification in noise
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
Measured: 8 weeks
phoneme identification in noise
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
Measured: 12 weeks
Secondary outcomes (16)
The temporal modulation Transfer function
With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.
Measured: 0 weeks
The temporal modulation Transfer function
With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.
Measured: 4 weeks
The temporal modulation Transfer function
With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.
Measured: 8 weeks
The temporal modulation Transfer function
With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.
Measured: 12 weeks
Dual-task listening postural control
This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.
Measured: 0 weeks
Dual-task listening postural control
This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.
Measured: 4 weeks
Dual-task listening postural control
This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.
Measured: 8 weeks
Dual-task listening postural control
This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.
Measured: 12 weeks
Stroop task
The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.
Measured: 0 weeks
Stroop task
The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.
Measured: 4 weeks
Stroop task
The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.
Measured: 8 weeks
Stroop task
The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself.
Measured: 12 weeks
EAS (Effort Assessment Scale)
EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.
Measured: 0 weeks
EAS (Effort Assessment Scale)
EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.
Measured: 4 weeks
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.
Measured: 0 weeks
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start3 Apr 2023
- Primary completion5 Feb 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hearing DisabilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Van Wieringen, PhD, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Astrid van Wieringen, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766020
- Sponsor's protocol ID
- S63310
- Acronym
- TRAILS
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Wieringen A, Wouters J. Natural vowel and consonant recognition by Laura cochlear implantees. Ear Hear. 1999 Apr;20(2):89-103. doi: 10.1097/00003446-199904000-00001.
PubMed 10229511van Wieringen A, Wouters J. LIST and LINT: sentences and numbers for quantifying speech understanding in severely impaired listeners for Flanders and the Netherlands. Int J Audiol. 2008 Jun;47(6):348-55. doi: 10.1080/14992020801895144.
PubMed 18569107Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.
PubMed 6615338Alhanbali S, Dawes P, Lloyd S, Munro KJ. Self-Reported Listening-Related Effort and Fatigue in Hearing-Impaired Adults. Ear Hear. 2017 Jan/Feb;38(1):e39-e48. doi: 10.1097/AUD.0000000000000361.
PubMed 27541332Van Wilderode M, Van Humbeeck N, Krampe RT, van Wieringen A. Enhancing Speech Perception in Noise Through Home-Based Competing Talker Training. Ear Hear. 2025 Jul-Aug 01;46(4):856-870. doi: 10.1097/AUD.0000000000001631. Epub 2025 Feb 10.
PubMed 39924678
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Listening Skills With the Inclusion of Cognitive Control
- ClinicalTrials.gov ID
- NCT05766020
- Acronym / sponsor ID
- TRAILS / S63310
- Conditions
- Hearing Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Mar 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.
Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.
Detailed description
Goals of the study:
- Investigate transfer of listening skills to non-trained listening.
- To develop evidence-based guidelines for clinical audiological rehabilitation.
- Investigate if the inclusion of cognitive control frees up cognitive resources to use for another concurrent task.
- Inform about retention following listening training
All participants will be assessed 4 times, with a 4-week interval in between. Participants in the first arm will perform the training during the first two weeks. 4 weeks after training ended and 8 weeks after training ended, retention of training gains will be assessed. Participants in the second arm will perform the delayed training. This is to control for procedural learning effects. After 4 weeks they will start training for 4 weeks. After training retention of training gains will be assessed after 4 weeks. The third arm will start with active control training (listening to stories) for 4 weeks, followed by training for 4 weeks. After these 8 weeks, retention was measured 4 weeks later. Participants are randomly allocated to a group. The efficacy of training will be determined with a within-subject design (i.e. baseline session outcomes will be compared to the final session outcomes of the randomized control trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate training group | Experimental | Behavioral: Listen trainingParticipants in this group will train immediately for 4 weeks. Afterwards, they will not train for the 8 remaining weeks. |
| Delayed Training Group | Experimental | Behavioral: Listen trainingParticipants in this group will receive delayed training after 4 weeks of no training. |
| Active control group | Experimental | Behavioral: Listen trainingParticipants in this group will perform an active control for 4 weeks, followed by 4 weeks of training. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clients who experience listening and communication difficulties.
- Clients must not undergo any audiological rehabilitation (auditory training/hearing aid fitting) during the study.
- Able to operate the training programme as an app on a tablet (e.g. clients have sufficient eyesight to see the exercises; clients must be able to operate the programme).
- At least 18 years old.
- Dutch-speaking, as all training material and counselling questions will be presented in Dutch.
Key exclusion criteria (3 listed)
- Severely visually impaired
- Motorically impaired
- Cognitively impaired
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 |
|---|---|---|
| Listen trainingAuditory skills with the inclusion of cognitive control. | Behavioural | Active control group, Delayed Training Group, Immediate training group |
Primary outcome
Speech in noise intelligibility
Time frame: 0 weeks
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Speech in noise intelligibility
Time frame: 4 weeks
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Speech in noise intelligibility
Time frame: 8 weeks
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
Speech in noise intelligibility
Time frame: 12 weeks
LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.
phoneme identification in noise
Time frame: 0 weeks
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
phoneme identification in noise
Time frame: 4 weeks
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
phoneme identification in noise
Time frame: 8 weeks
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
phoneme identification in noise
Time frame: 12 weeks
The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.
16 secondary outcomes
The temporal modulation Transfer function
Time frame: 0 weeks
The temporal modulation Transfer function
Time frame: 4 weeks
The temporal modulation Transfer function
Time frame: 8 weeks
The temporal modulation Transfer function
Time frame: 12 weeks
Dual-task listening postural control
Time frame: 0 weeks
Dual-task listening postural control
Time frame: 4 weeks
Dual-task listening postural control
Time frame: 8 weeks
Dual-task listening postural control
Time frame: 12 weeks
Stroop task
Time frame: 0 weeks
Stroop task
Time frame: 4 weeks
Stroop task
Time frame: 8 weeks
Stroop task
Time frame: 12 weeks
EAS (Effort Assessment Scale)
Time frame: 0 weeks
EAS (Effort Assessment Scale)
Time frame: 4 weeks
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: 0 weeks
SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 10229511van Wieringen A, Wouters J. Natural vowel and consonant recognition by Laura cochlear implantees. Ear Hear. 1999 Apr;20(2):89-103. doi: 10.1097/00003446-199904000-00001.
- Background: PubMed 18569107van Wieringen A, Wouters J. LIST and LINT: sentences and numbers for quantifying speech understanding in severely impaired listeners for Flanders and the Netherlands. Int J Audiol. 2008 Jun;47(6):348-55. doi: 10.1080/14992020801895144.
- Background: PubMed 6615338Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.
- Background: PubMed 27541332Alhanbali S, Dawes P, Lloyd S, Munro KJ. Self-Reported Listening-Related Effort and Fatigue in Hearing-Impaired Adults. Ear Hear. 2017 Jan/Feb;38(1):e39-e48. doi: 10.1097/AUD.0000000000000361.
- Derived from this study: PubMed 39924678Van Wilderode M, Van Humbeeck N, Krampe RT, van Wieringen A. Enhancing Speech Perception in Noise Through Home-Based Competing Talker Training. Ear Hear. 2025 Jul-Aug 01;46(4):856-870. doi: 10.1097/AUD.0000000000001631. Epub 2025 Feb 10.
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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.
Astrid van Wieringen, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listen training in people with Hearing Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 9 Aug 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in noise intelligibility (time frame: 0 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766020, which also lists 5 linked publications.
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 9 Aug 2024.