Hearing Loss, Bilateral or UnilateralSCEDuLLNCT07028658
Effectiveness of Speech Therapy for Lip-reading in Patients With Hearing Aids: SCED Study
An observational study of Hearing Loss, Bilateral or Unilateral, run by Institut Pasteur at 1 site in France.
Trial summary
This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral
- What is being tested?
- Speechreading training
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of hearing-impaired individuals with hearing aids
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cabinet d'orthophonie
Paris, 75008
Aurensan, +33986301929, orthophoniste.roxane@gmail.com
About this study
Official title: Efficacité de la rééducation Orthophonique de la Lecture Labiale Des Patients appareillés Auditifs : étude SCED
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
- Being tested
- Speechreading training
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speechreading trainingOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality
Measured: 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
Measured: 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
Measured: 26 sessions (4,5 months)
Repetition score of sentences on video support in audiovisual modality
Measured: 26 sessions (4,5 months)
Identification score of two sequences of musical notes
Measured: 26 sessions (4,5 months)
Impact of speech therapy rehabilitation on quality of life
AVS from 0 to 10
Measured: 26 sessions (4,5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start16 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028658
- Sponsor's protocol ID
- 2024-135_SCEDuLL
- Other IDs
- 2025-A00506-23
- Acronym
- SCEDuLL
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacité de la rééducation Orthophonique de la Lecture Labiale Des Patients appareillés Auditifs : étude SCED
- ClinicalTrials.gov ID
- NCT07028658
- Acronym / sponsor ID
- SCEDuLL / 2024-135_SCEDuLL
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether lip reading rehabilitation improves viseme recognition in individuals with hearing impairments who use hearing aids.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of hearing-impaired individuals with hearing aids
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speechreading trainingThe 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 | Other | – |
Primary outcome
Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality
Time frame: 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
Time frame: 26 sessions (4,5 months)
4 secondary outcomes
Repetition score of 10 non-words on recorded support with a Signal-to-Noise Ratio of 10
Time frame: 26 sessions (4,5 months)
Repetition score of sentences on video support in audiovisual modality
Time frame: 26 sessions (4,5 months)
Identification score of two sequences of musical notes
Time frame: 26 sessions (4,5 months)
Impact of speech therapy rehabilitation on quality of life
Time frame: 26 sessions (4,5 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Bilateral or Unilateral, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetition score, in words (with and without labial doppelganger) of Lafon's cochlear lists presented on video support in visual-only modality (time frame: 26 sessions (4,5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.