An interventional study of Speech Enhancer in Listening Effort, sponsored by Sonova AG. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
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.
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.
Sonova AG is the lead sponsor of 89 studies on the registry; 6 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The hearing impaired group will compare the reference condition (SpeechEnhancer on) with the intervention condition (SpeechEnhancer off).
Other: Speech Enhancer
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
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.
Time frame: 10 weeks
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.
Time frame: 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).
Time frame: 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).
Time frame: 10 weeks
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Dec 2023, 2 months after the start.
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