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

NCT05237180 | Completed

• 1 other identifier: 2021/CHU/32
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Cochlear

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

patient group

EXPERIMENTAL

8 training sessions on spatial localisation

Other: spatial localisation training

control croup

NO INTERVENTION

Non training sessions

Interventions

spatial localisation training OTHER

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

patient group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Gcs Crcsi

Sainte-Clotilde, Reunion

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justine MAISSON

  GCS CRCSI

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 14, 2022
• Study Start: February 15, 2022
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)