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Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension (CAudiBruit)

Primary Purpose

Hearing Loss, Cochlear

Status

Completed

Phase

Not Applicable

Locations

Réunion

Study Type

Interventional

Intervention

spatial localisation training

About this trial

This is an interventional supportive care trial for Hearing Loss, Cochlear

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

post-lingual deafness
implanted bilaterally for at least 1 year
score ≥ 70 at LAFON scale
score ≥ 70 at MBAA scale
score ≥ 5/9 at CAP scale
good command of the French language
accepts to participate in the study

Exclusion Criteria:

do not realize speech reeducation (spatial localisation and speech perception) during the study
no change in setting of cochlear implants

Sites / Locations

Gcs Crcsi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patient group

control croup

Arm Description

8 training sessions on spatial localisation

Non training sessions

Outcomes

Primary Outcome Measures

Change of Hearing comprehension performance in noise

MBAA (Marginal Benefic from Acoustical Amplification) scale. Minimal score = 0 and maximal score =540. minimum score means that the patient is unable to repeat phrases and maximal score means that the patient is able to repeats all phrases.

Change of Hearing comprehension performance in noise

15iSSQ (New 15 items Speech Spatial and qualities of hearing Scale Shoirt Form). Minimum score =0 and maximal score = 150. maximal score means that the patient has a good quality of life and minimum score means that his quality of life is bad. It is a qualitative evaluation.

Secondary Outcome Measures

Full Information

NCT ID

NCT05237180

First Posted

January 10, 2022

Last Updated

October 19, 2022

Sponsor

Centre Hospitalier Universitaire de la Réunion

1. Study Identification

Unique Protocol Identification Number

NCT05237180

Brief Title

Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension

Acronym

CAudiBruit

Official Title

Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension in Noise in Bi-implanted Subjects With Post-lingual Deafness

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. However, only few studies have investigated the effect of spatial localization training on listening comprehension performance in noise. None of these studies correspond to the desire to purpose training by speech therapists while using affordable equipment. The main objective of this study is to evaluate the effect of a spatial localization training protocol in cochlear bi-implanted subjects with post-lingual deafness on their ability to understand in noise. 2 groups of 10 subjects each will be recruited: a patient group and a control group. The patient group will undergo 8 sessions of spatial localization rehabilitation lasting an average of 45 minutes each. After this programme, the pre-test and post- test results obtained will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Cochlear

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patient group

Arm Type

Experimental

Arm Description

8 training sessions on spatial localisation

Arm Title

control croup

Arm Type

No Intervention

Arm Description

Non training sessions

Intervention Type

Other

Intervention Name(s)

spatial localisation training

Intervention Description

8 spatial localization training sessions MBAA and SSQ tests before and after training sessions.

Primary Outcome Measure Information:

Title

Change of Hearing comprehension performance in noise

Description

Time Frame

10 weeks after inclusion

Title

Change of Hearing comprehension performance in noise

Description

Time Frame

10 weeks after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: post-lingual deafness implanted bilaterally for at least 1 year score ≥ 70 at LAFON scale score ≥ 70 at MBAA scale score ≥ 5/9 at CAP scale good command of the French language accepts to participate in the study Exclusion Criteria: do not realize speech reeducation (spatial localisation and speech perception) during the study no change in setting of cochlear implants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justine MAISSON

Organizational Affiliation

GCS CRCSI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gcs Crcsi

City

Sainte Clotilde

Country

Réunion

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension

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