NCT06049199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 29, 2023

Last Update Submit

November 28, 2023

Conditions

Listening Effort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • EEG alpha power measured during Listening Span Task (LST)

    10 weeks

  • Listening effort (ACALES) measured during Listening Effort Task (LET)

    10 weeks

  • Working memory measured with Listening Span Task (LST)

    10 weeks

Study Arms (1)

Hearing impaired group

EXPERIMENTAL

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

Other: Speech Enhancer

Interventions

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

Hearing impaired group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hörzentrum Oldenburg

Oldenburg, Lower Saxony, 26129, Germany

Location

Related Publications (3)

  • 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.

    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.

    PMID: 28679238RESULT

  • 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.

    RESULT

Study Officials

  • Matthias Vormann

    Hörzentrum Oldeburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 22, 2023

Study Start

October 16, 2023

Primary Completion

December 22, 2023

Study Completion

March 31, 2024

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)