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

NCT07028658 | Not Yet Recruiting

• 2 other identifiers: 2024-135_SCEDuLL2025-A00506-23
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hearing Loss, Bilateral or Unilateral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Interventions

Speechreading training OTHER

The patient will undergo 16 lip reading training sessions. By developing functional lip reading skills, they will be able to fill in the gaps in auditory information they miss, especially in loud or noisy settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of hearing-impaired individuals with hearing aids

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead
• IHU reConnect: collaborator

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06