Effect of Speech Enhancer on Listening Effort With EEG

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Listening Effort
• Intervention / Treatment: Other: Speech Enhancer

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 Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Habicht; Phone Number: +41 58 928 85 38; Email: julia.habicht@sonova.com
• Study Contact Backup: Name: Martina Schuepbach-Wolf; Phone Number: +41 58 928 86 79; Email: Martina.Schuepbach-Wolf@sonova.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hearing impaired group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	10 weeks

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Hoerzentrum Oldenburg

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2023
• Primary Completion (Estimated): December 22, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 15063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No