Listening EffortNCT06049199
Effect of Speech Enhancer on Listening Effort With EEG
A study testing Speech Enhancer in people with Listening Effort, run by Sonova AG at 1 site in Germany.
Trial summary
In previous studies, Speech Enhancer has been shown to improve Listening Effort using a subjective method. To overcome the weakness of subjective testing, this study uses an objective measurement that has shown convincing results in previous studies addressing Listening Effort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Listening Effort
- What is being tested?
- Speech Enhancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2023to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz),
- Sensorineural hearing loss,
- Air Conduction - bone conduction gap <= 10 dB,
- Written and spoken German,
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- Ability to understand instruction,
- Ability to describe listening experiences,
- Ability to attend to the appointments,
- Healthy outer ear (without previous surgical proce-dures),
- Hearing loss within the fitting ranges of the investiga-tional product,
- Informed consent as documented by signature.
Who cannot join
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results,
- Limited mobility and not in the position to attend all appointments,
- Inability to produce a reliable hearing test result,
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- Massively limited dexterity,
- Known psychological problems,
- Known central hearing disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess the Effect of Speech Enhancer on Listening Effort With EEG
In previous studies, Speech Enhancer has been shown to improve Listening Effort using a subjective method. To overcome the weakness of subjective testing, this study uses an objective measurement that has shown convincing results in previous studies addressing Listening Effort.
Read the detailed description
The Speech Enhancer (SE) provides better speech intelligibility for soft speech while maintaining the same sound quality for loud input level.
Better speech intelligibility may also result in less listening effort in some circumstances. So there was the hope that the SE provides better speech intelligibility and less listening effort for situation with soft speech.
The SE has already been intensely and successfully investigated in early studies.
The cognitive performance on a neurophiosiological level has already been successfully investigated in a previous studies.
- Conditions
- Listening Effort
- Being tested
- Speech Enhancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech EnhancerOther
Speech Enhancer is an adaptive feature which increases the amplitude of speech signal when speech is detected. Speech Enhancer will be switched on and off for the Intervention
| Study group | Role | What they receive |
|---|---|---|
| Hearing impaired group | Experimental | The hearing impaired group will compare the reference condition (SpeechEnhancer on) with the intervention condition (SpeechEnhancer off). Receives: Other: Speech Enhancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG alpha power measured during Listening Effort Task (LET)
During the LET experiment EEG data will be recorded while participants perform the Adaptive CAtegorical Listening Effort (ACALES). Participants will be equipped with an EEG cap. A continuous EEG will be recorded while participants are performing the LET. Based on the EEG data the alpha power will be analysed offline afterwards.
Measured: 10 weeks
Secondary outcomes (3)
EEG alpha power measured during Listening Span Task (LST)
During the LST experiment EEG data will be recorded while participants perform the Working Memory Test. Participants will be equipped with an EEG cap. A continuous EEG will be recorded while participants are performing the LST. Based on the EEG data the alpha power will be analysed offline afterwards.
Measured: 10 weeks
Listening effort (ACALES) measured during Listening Effort Task (LET)
The speech material of the ACALES is based on the German OLSA sentence matrix test. All sentences are syntactically identical and consist of five word categories (name, verb, number, adjective, and object, e.g., "Peter kauft fünf rote Blumen" [engl. "Peter buys five red flowers"]). Each trial consists of a sequence of three (different) sentences, after which participants are asked to rate their perceived listening effort on a scale via touch screen. The scale ranges from 1 (no effort) to 13 (extreme effort) based on the ACALES. These values (effort scaling units - ESCU) constitute the subjective behavioral data regarding the personal experience of listening effort.
The ACALES is part of the LET experiment and is therefore combined with EEG recordings (see outcome 1).
Measured: 10 weeks
Working memory measured with Listening Span Task (LST)
The material in the LST task is taken from the Basler sentence test. Half of the sentences are high predictable sentences (HP) and the other half were low predictable (LP) sentences. The participants' task is to repeat the sentence they hear and remember the last word of each sentence. After four sentences, the participants is asked to recall the final words of the last four sentences. The experimenter scores the number of correctly repeated final words after each sentence (words recognized) as well as the number of correctly recalled final words (words remembered). Based on this, a relative memory score is calculated.
The Working Memory Test is part of the LST and is therefore combined with EEG recordings (see outcome 2).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start16 Oct 2023
- Primary completion22 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Listening EffortStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoerzentrum Oldenburg
- Responsible party
- Sponsor
- Investigators
- Matthias Vormann, Principal investigator, Hörzentrum Oldeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049199
- Sponsor's protocol ID
- 15063
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagener, K. B. (1999). Development and evaluation of a German sentence test Part II: Optimization of the Oldenburg sentence test. . Zeitschrift Fur Audiologie,, 38, 44-56.
Krueger M, Schulte M, Brand T, Holube I. Development of an adaptive scaling method for subjective listening effort. J Acoust Soc Am. 2017 Jun;141(6):4680. doi: 10.1121/1.4986938.
PubMed 28679238Tschopp K, I. L. (1992). Die Entwicklung einer deutschen Version des SPIN-Tests (Speech Perception in Noise). In: B. Kollmeier (Hrsg): Moderne Ver-fahren der Sprachaudiometrie. . Heidelberg, Median-Verlag,, 311-329.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Effect of Speech Enhancer on Listening Effort With EEG
- ClinicalTrials.gov ID
- NCT06049199
- Acronym / sponsor ID
- 15063
- Conditions
- Listening Effort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Hoerzentrum Oldenburg
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 22 Sep 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.
In previous studies, Speech Enhancer has been shown to improve Listening Effort using a subjective method. To overcome the weakness of subjective testing, this study uses an objective measurement that has shown convincing results in previous studies addressing Listening Effort.
Detailed description
The Speech Enhancer (SE) provides better speech intelligibility for soft speech while maintaining the same sound quality for loud input level.
Better speech intelligibility may also result in less listening effort in some circumstances. So there was the hope that the SE provides better speech intelligibility and less listening effort for situation with soft speech.
The SE has already been intensely and successfully investigated in early studies.
The cognitive performance on a neurophiosiological level has already been successfully investigated in a previous studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing impaired group | Experimental | Other: Speech EnhancerThe hearing impaired group will compare the reference condition (SpeechEnhancer on) with the intervention condition (SpeechEnhancer off). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Symmetrical hearing loss (difference between ears <= 10 dB for 1kHz-6kHz),
- Sensorineural hearing loss,
- Air Conduction - bone conduction gap <= 10 dB,
Key exclusion criteria (9 listed)
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results,
- Limited mobility and not in the position to attend all appointments,
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 |
|---|---|---|
| Speech EnhancerSpeech Enhancer is an adaptive feature which increases the amplitude of speech signal when speech is detected. Speech Enhancer will be switched on and off for the Intervention | Other | Hearing impaired group |
Primary outcome
EEG alpha power measured during Listening Effort Task (LET)
Time frame: 10 weeks
During the LET experiment EEG data will be recorded while participants perform the Adaptive CAtegorical Listening Effort (ACALES). Participants will be equipped with an EEG cap. A continuous EEG will be recorded while participants are performing the LET. Based on the EEG data the alpha power will be analysed offline afterwards.
3 secondary outcomes
EEG alpha power measured during Listening Span Task (LST)
Time frame: 10 weeks
Listening effort (ACALES) measured during Listening Effort Task (LET)
Time frame: 10 weeks
Working memory measured with Listening Span Task (LST)
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Results publicationWagener, K. B. (1999). Development and evaluation of a German sentence test Part II: Optimization of the Oldenburg sentence test. . Zeitschrift Fur Audiologie,, 38, 44-56.
- Results publication: PubMed 28679238Krueger M, Schulte M, Brand T, Holube I. Development of an adaptive scaling method for subjective listening effort. J Acoust Soc Am. 2017 Jun;141(6):4680. doi: 10.1121/1.4986938.
- Results publicationTschopp K, I. L. (1992). Die Entwicklung einer deutschen Version des SPIN-Tests (Speech Perception in Noise). In: B. Kollmeier (Hrsg): Moderne Ver-fahren der Sprachaudiometrie. . Heidelberg, Median-Verlag,, 311-329.
- 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.
Matthias Vormann principal investigator
Hörzentrum Oldeburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Enhancer in people with Listening Effort, run by Sonova AG at 1 site in Germany.
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 12 inclusion and 9 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 4 Dec 2023. 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 Germany. 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?
EEG alpha power measured during Listening Effort Task (LET) (time frame: 10 weeks). 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 NCT06049199, which also lists 3 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 4 Dec 2023.