NCT03512951

Brief Summary

Within the course of this study, a signal processing feature has been developed at Ecole Polytechnique Fédérale de Lausanne (EPFL), in collaboration with Sonova AG, in order to enhance the listening experience with remote microphone systems. In particular, the developed feature is supposed to improve the so-called audio-visual fusion, i.e. the fact to perceive the sound as coming from the physical location of the source. One of the main goals of the present study is to evaluate the extent to which this feature reaches that objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

April 17, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

April 17, 2018

Last Update Submit

December 19, 2018

Conditions

Hearing DisordersHearing Loss, Sensorineural

Keywords

Hearing aidsRemote microphone systemsRoger technologySound externalizationAuditory distance estimation

Outcome Measures

Primary Outcomes (1)

  • Auditory distance estimation

    This objective is assessed by using a single outcome, which is the perceived auditory distance, as reported by the patient on a graphical user interface. The auditory distance is measured using an arbitrary scale (between 1 and 5) as available with sliders on a graphical user interface (GUI).

    6 months (study completion)

Study Arms (3)

Normal hearing

EXPERIMENTAL

A control group including ten normal-hearing participants. These participants are recruited because they can be considered as a reference when compared to hearing-impaired patients. They usually provide homogeneous results that are expected to be significantly different than those obtained with hearing-impaired patients. In this study, normal-hearing participants are expected to provide better and more consistent performance of auditory distance estimation.

Other: Digital signal processing algorithms

10 experienced hearing impaired

EXPERIMENTAL

A group of ten (expected sample size) severe-to-profound hearing-impaired patients who have a past and/or present experience of more than 6 months with remote microphone systems. These patients are expected to be aware of the drawbacks of the current remote microphone technology with respect to sound localization, auditory distance estimation, and audio-visual fusion.

Other: Digital signal processing algorithms

10 naive hearing impaired

EXPERIMENTAL

A group of ten severe-to-profound hearing-impaired patients with no past or current experience with remote microphone systems. They are referred to as naïve patients. These patients must have similar profiles to the patients in the experienced group as regards the degree of hearing loss, origin of hearing loss (congenital, pre- or post-lingual disability), age, gender, and hearing aid technology. They will be selected and recruited on the basis of the patients included in experienced group

Other: Digital signal processing algorithms

Interventions

Digital signal processing algorithmsOTHER

The intervention consists in applying five processing on some recorded speech signals. In particular, the processing performed by one specific algorithm is compared against the four other. The applied processing is supposed to restore sound externalization (expected audio-visual fusion).

10 experienced hearing impaired10 naive hearing impairedNormal hearing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing and able to give written informed consent as documented by signature,
  • French-native adult speakers,
  • (Preferably) younger than 60 y.o.
  • For all normal-hearing participants:
  • \- Hearing thresholds lower or equal to 20 dB on both ears, as ensured by a pure-tone audiometry (125 Hz to 8 kHz) conducted at the beginning of the session.
  • For all hearing-impaired patients:
  • Patients of Mr. Philippe Estoppey, private audiologist settled in Lausanne,
  • User of bilateral BTE Phonak hearing aids, commercialized after July 2012, with fittings that did not change over the last three months,
  • Presenting a severe-to-profound sensorineural hearing loss,
  • Presenting a symmetrical hearing loss (no bilateral hearing threshold that differ by more than 20 dB at any audiometric frequency (125 Hz - 4 kHz)).
  • For HI patients experienced with remote microphone systems:
  • \- Past or present users of FM and/or Roger devices for more than six months.
  • For other HI patients:
  • \- No past or present experience with FM and/or Roger devices for more than one month.

You may not qualify if:

  • Collaborator of the laboratory (LTS2) or student attending the courses of audio and acoustics given by the laboratory staff (EE-348 Electroacoustics, EE-548 Audio Engineering),
  • History of chronic or terminal illness, psychiatric disturbance, senile dementia, or cognitive impairment,
  • History of strong tinnitus and/or hyperacusis,
  • Strong visual impairment after correction with glasses or not,
  • History of epilepsy or other reactions associated with the proximity to a screen,
  • Motor disability that would disturb their presence at EPFL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ecole Polytechnique Fédérale de Lausanne

Lausanne, Canton of Vaud, 1015, Switzerland

Location

Ecole Polytechnique Fédérale de Lausanne

Lausanne, 1015, Switzerland

Location

Related Publications (1)

  • Courtois G, Grimaldi V, Lissek H, Estoppey P, Georganti E. Perception of Auditory Distance in Normal-Hearing and Moderate-to-Profound Hearing-Impaired Listeners. Trends Hear. 2019 Jan-Dec;23:2331216519887615. doi: 10.1177/2331216519887615.

    PMID: 31774032DERIVED

MeSH Terms

Conditions

Hearing DisordersHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 1, 2018

Study Start

October 9, 2018

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)