Clinical trial NCT06049199: Effect of Speech Enhancer on Listening Effort With EEG
Official title: Assess the Effect of Speech Enhancer on Listening Effort With EEG
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Listening Effort
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Hoerzentrum Oldenburg
First posted: 2023-09-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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.

Exclusion Criteria:

* 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,
* Massively limited dexterity,
* Known psychological problems,
* Known central hearing disorders.

Primary outcomes:
measure: EEG alpha power measured during Listening Effort Task (LET)
timeFrame: 10 weeks
Secondary outcomes:
measure: EEG alpha power measured during Listening Span Task (LST)
timeFrame: 10 weeks
measure: Listening effort (ACALES) measured during Listening Effort Task (LET)
timeFrame: 10 weeks
measure: Working memory measured with Listening Span Task (LST)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg
state: Niedersachsen
Study officials:
affiliation: Hörzentrum Oldeburg
name: Matthias Vormann
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Tschopp 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.