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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05237180
Other study ID # 2021/CHU/32
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date March 1, 2022

Study information

Verified date January 2022
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Réunion Gcs Crcsi Sainte Clotilde

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 weeks after inclusion
Primary 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.
10 weeks after inclusion
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