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Effect of Speech Enhancer on Listening Effort With EEG

NCT ID: NCT06049199

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-03-31

Brief Summary

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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

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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

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Listening Effort

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hearing impaired group

The hearing impaired group will compare the reference condition (SpeechEnhancer on) with the intervention condition (SpeechEnhancer off).

Group Type EXPERIMENTAL

Speech Enhancer

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoerzentrum Oldenburg

UNKNOWN

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Vormann

Role: PRINCIPAL_INVESTIGATOR

Hörzentrum Oldeburg

Locations

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Hörzentrum Oldenburg

Oldenburg, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 28679238 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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15063

Identifier Type: -

Identifier Source: org_study_id