Effectiveness of Speech Therapy for Lip-reading in Patients With Hearing Aids: SCED Study

Not yet recruiting

• Conditions: Hearing Loss, Bilateral or Unilateral

• Registration Number: NCT07028658
• Lead Sponsor: Institut Pasteur

Brief Summary

This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-09
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patient aged 18 or older
• Affiliated with a social security system
• Moderate to severe bilateral post-lingual hearing loss, fitted with hearing aids for more than 6 months
• Wearing hearing aids for a minimum of 8 hours/day on average over the past month
• Intelligibility in quiet > 80% correct responses at 60 dB (Lafon cochlear list)
• Difficulty in noisy environments rated > 6 on a 0-10 EVA scale
• French language comprehension level of at least B1 CEFR (Common European Framework of Reference for Languages)
• Willing to participate in speech therapy rehabilitation at a rate of 2 sessions per week

Exclusion Criteria

• Patient who has already undergone speech therapy rehabilitation as part of their hearing loss treatment
• Diagnosis of neurodegenerative disease or history of brain injury (traumatic brain injury, stroke, tumor, meningitis, etc.)
• Uncorrected vision or visual impairment affecting lip reading (e.g. AMD, glaucoma, unoperated cataract, etc.)
• Presence of severe tinnitus (score > 56) on the Tinnitus Handicap Inventory (THI) questionnaire
• Significant cognitive impairment (CODEX C or D) or Montreal Cognitive Assessment (MOCA) score < 23

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality	26 sessions (4,5 months)
Repetition score, in visemes (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality	26 sessions (4,5 months)

Secondary Outcome Measures

Name	Time	Method
Repetition score of 10 non-words on recorded support with a Signal-to-Noise Ratio of 10	26 sessions (4,5 months)
Repetition score of sentences on video support in audiovisual modality	26 sessions (4,5 months)
Identification score of two sequences of musical notes	26 sessions (4,5 months)
Impact of speech therapy rehabilitation on quality of life	26 sessions (4,5 months)	AVS from 0 to 10