Hearing Loss, Age-RelatedAUDISSEENCT05848661
Evaluation of a Digital Therapy of Auditory Training
A study testing AUDISSEE in people with Hearing Loss, Age-Related, run by Humans Matter.
Trial summary
The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Age-Related
- What is being tested?
- AUDISSEE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age over 18
- No neurological or psychiatric background
- No major cognitive deficit, able to understand and apply the recommendation
- Motivated to participate
- Have given its written consent
- Affiliated to a social security system
Show all 10Show fewer
- Diagnostic of presbycusis by a health professional
- Hearing-aids since less than 2 years (no cochlear implants)
- No tinnitus
- With a possible access to a personal computer, tactile tablet or smart-phone to perform the training
Who cannot join
- Age below 18
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training
The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids.
Read the detailed description
AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. This therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. It is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe).
In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
Each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. The protocol lasts 20 weeks in total for each patient.
- Conditions
- Hearing Loss, Age-Related
- Being tested
- AUDISSEE, Placebo
- Keywords
- Hearing aid, presbycusis, auditory training, hearing in noise
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUDISSEEDevice
AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal stimuli. The therapy takes place over 10 weeks with 3 sessions of 20 minutes per week.
PlaceboDevice
The Placebo is a therapy designed within the same frame as the AUDISSEE therapy but with no auditory exercises, instead the patients are listening to audiobook. The therapy takes place over 10 weeks, with 3 sessions of 20 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo | Experimental | In this arm, the group will perform first the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. Then it will perform the placebo training for 10 weeks.
The AUDISSEE therapy takes place over 10 weeks with 3 sessions of 20 minutes per week. It is divided into two parts (5 weeks for each part):
* verbal training exercises in noise that are specifically aimed at improving patients' intelligibility in noise
* non-verbal training exercises using environmental sounds and musical sounds, which are specifically aimed at improving non-verbal auditory perception Receives: Device: AUDISSEE; Device: Placebo |
| AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo | Experimental | In this arm, the group will perform first the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. Then it will perform the placebo training for 10 weeks. Receives: Device: AUDISSEE; Device: Placebo |
| Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal | Placebo comparator | In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training.
At each session of the placebo therapy, the patient will listen to an excerpt from an audio-book or podcast of similar length to the duration of the training exercises (20 min).
This therapy engages the patient in a similar manner than the AUDISSEE therapy in terms of time spent (same session frequency, same session duration), but does not specifically train auditory perception networks. Receives: Device: AUDISSEE; Device: Placebo |
| Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal | Placebo comparator | In this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. Receives: Device: AUDISSEE; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Measured: 5 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Measured: 5 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Measured: 10 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Measured: 10 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Measured: 15 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Measured: 15 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Measured: 20 weeks to baseline
Hearing in noise
Measure of speech-in-noise comprehension using vocal audiometry (FrBio):
Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Measured: 20 weeks to baseline
Secondary outcomes (32)
Quality of life and hearing : personal efficacy
Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
Measured: 5 weeks to baseline
Quality of life and hearing : listening effort
Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 5 weeks to baseline
Quality of life and hearing : spatial learning abilities
Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 5 weeks to baseline
Quality of life and hearing: personal efficacy
Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
Measured: 10 weeks to baseline
Quality of life and hearing: listening effort
Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 10 weeks to baseline
Quality of life and hearing: spatial learning abilities
Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 10 weeks to baseline
Quality of life and hearing: personal efficacy
Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
Measured: 15 weeks to baseline
Quality of life and hearing: listening effort
Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 15 weeks to baseline
Quality of life and hearing: spatial learning abilities
Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 15 weeks to baseline
Quality of life and hearing: personal efficacy
Questionnaire for the feeling of personal efficacy:14 items with a 5-pt likert scale, a mean score is measured (between 1 and 5)
Measured: 20 weeks to baseline
Quality of life and hearing: listening effort
Questionnaire for the listening effort: 10 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 20 weeks to baseline
Quality of life and hearing: spatial learning abilities
Questionnaire for the spatial learning abilities (SSQ15): 15 items with a 10-points likert scale, a mean score is measured (between 1 and 10)
Measured: 20 weeks to baseline
Non-verbal auditory testing :pitch change detection task
Battery of listening tests for non-verbal auditory cognition assessment:
- Pitch Change Detection task: percentage of correct responses
Measured: 5 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Battery of listening tests for non-verbal auditory cognition assessment:
- Direction of pitch change identification task: percentage of correct responses
Measured: 5 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Battery of listening tests for non-verbal auditory cognition assessment:
- Short term memory for pitch task: percentage of correct responses
Measured: 5 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Battery of listening tests for non-verbal auditory cognition assessment:
- Emotional prosody recognition task: perception of correct responses
Measured: 5 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Battery of listening tests for non-verbal auditory cognition assessment:
- Auditory Streaming separation task: mean frequency (in Hz) of perception change between 1 and 2 streams
Measured: 5 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Battery of listening tests for non-verbal auditory cognition assessment:
- Pitch Change Detection task: percentage of correct responses
Measured: 10 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Battery of listening tests for non-verbal auditory cognition assessment:
- Direction of pitch change identification task: percentage of correct responses
Measured: 10 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Battery of listening tests for non-verbal auditory cognition assessment:
- Short term memory for pitch task: percentage of correct responses
Measured: 10 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Battery of listening tests for non-verbal auditory cognition assessment:
- Emotional prosody recognition task: perception of correct responses
Measured: 10 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Battery of listening tests for non-verbal auditory cognition assessment:
- Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
Measured: 10 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Battery of listening tests for non-verbal auditory cognition assessment:
- Pitch Change Detection task: percentage of correct responses
Measured: 15 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Battery of listening tests for non-verbal auditory cognition assessment:
- Direction of pitch change identification task: percentage of correct responses
Measured: 15 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Battery of listening tests for non-verbal auditory cognition assessment:
- Short term memory for pitch task: percentage of correct responses
Measured: 15 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Battery of listening tests for non-verbal auditory cognition assessment:
- Emotional prosody recognition task: perception of correct responses
Measured: 15 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Battery of listening tests for non-verbal auditory cognition assessment:
- Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
Measured: 15 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Battery of listening tests for non-verbal auditory cognition assessment:
- Pitch Change Detection task: percentage of correct responses
Measured: 20 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Battery of listening tests for non-verbal auditory cognition assessment:
- Direction of pitch change identification task: percentage of correct responses
Measured: 20 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Battery of listening tests for non-verbal auditory cognition assessment:
- Short term memory for pitch task: percentage of correct responses
Measured: 20 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Battery of listening tests for non-verbal auditory cognition assessment:
- Emotional prosody recognition task: perception of correct responses
Measured: 20 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Battery of listening tests for non-verbal auditory cognition assessment:
- Auditory Streaming separation task : mean frequency (in Hz) of perception change between 1 and 2 streams
Measured: 20 weeks to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Age-RelatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humans Matter
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- agathe pralus, PhD, Study chair, Humans Matter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848661
- Sponsor's protocol ID
- 2023-A00248-37
- Acronym
- AUDISSEE
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training
- ClinicalTrials.gov ID
- NCT05848661
- Acronym / sponsor ID
- AUDISSEE / 2023-A00248-37
- Conditions
- Hearing Loss, Age-Related
- Keywords
- Hearing aid, presbycusis, auditory training, hearing in noise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Humans MatterIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 May 2023 (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.
The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids.
Detailed description
AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. This therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. It is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe).
In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
Each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. The protocol lasts 20 weeks in total for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
| Arm | Type | Receives |
|---|---|---|
| AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo | Experimental | Device: AUDISSEE, Device: PlaceboIn this arm, the group will perform first the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. Then it will perform the placebo training for 10 weeks. The AUDISSEE therapy takes place over 10 weeks with 3 sessions of 20 minutes per week. It is divided into two parts (5 weeks for each part): * verbal training exercises in noise that are specifically aimed at improving patients' intelligibility in noise * non-verbal training exercises using environmental sounds and musical sounds, which are specifically aimed at improving non-verbal auditory perception |
| AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo | Experimental | Device: AUDISSEE, Device: PlaceboIn this arm, the group will perform first the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. Then it will perform the placebo training for 10 weeks. |
| Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal | Placebo comparator | Device: AUDISSEE, Device: PlaceboIn this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the verbal sub-training then the non-verbal sub-training. At each session of the placebo therapy, the patient will listen to an excerpt from an audio-book or podcast of similar length to the duration of the training exercises (20 min). This therapy engages the patient in a similar manner than the AUDISSEE therapy in terms of time spent (same session frequency, same session duration), but does not specifically train auditory perception networks. |
| Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal | Placebo comparator | Device: AUDISSEE, Device: PlaceboIn this arm, the group will perform first placebo training for 10 weeks. Then, it will perform the AUDISSEE therapy starting with the non-verbal sub-training then the verbal sub-training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age over 18
- No neurological or psychiatric background
- No major cognitive deficit, able to understand and apply the recommendation
- Motivated to participate
- Have given its written consent
Key exclusion criteria (2 listed)
- Age below 18
- Pregnant or breastfeeding women
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 |
|---|---|---|
| AUDISSEEAUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal stimuli. The therapy takes place over 10 weeks with 3 sessions of 20 minutes per week. | Device | AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo, Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal |
| PlaceboThe Placebo is a therapy designed within the same frame as the AUDISSEE therapy but with no auditory exercises, instead the patients are listening to audiobook. The therapy takes place over 10 weeks, with 3 sessions of 20 minutes per week. | Device | AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo, Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal |
Primary outcome
Hearing in noise
Time frame: 5 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 5 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 10 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 10 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 15 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 15 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 20 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
Hearing in noise
Time frame: 20 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using CocktailParty noise and a SNR (Signal-to-Noise Ratio) of 10dB, a percentage of correct repetition of 20 sentences is measured
32 secondary outcomes
Quality of life and hearing : personal efficacy
Time frame: 5 weeks to baseline
Quality of life and hearing : listening effort
Time frame: 5 weeks to baseline
Quality of life and hearing : spatial learning abilities
Time frame: 5 weeks to baseline
Quality of life and hearing: personal efficacy
Time frame: 10 weeks to baseline
Quality of life and hearing: listening effort
Time frame: 10 weeks to baseline
Quality of life and hearing: spatial learning abilities
Time frame: 10 weeks to baseline
Quality of life and hearing: personal efficacy
Time frame: 15 weeks to baseline
Quality of life and hearing: listening effort
Time frame: 15 weeks to baseline
Quality of life and hearing: spatial learning abilities
Time frame: 15 weeks to baseline
Quality of life and hearing: personal efficacy
Time frame: 20 weeks to baseline
Quality of life and hearing: listening effort
Time frame: 20 weeks to baseline
Quality of life and hearing: spatial learning abilities
Time frame: 20 weeks to baseline
Non-verbal auditory testing :pitch change detection task
Time frame: 5 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Time frame: 5 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Time frame: 5 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Time frame: 5 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Time frame: 5 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Time frame: 10 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Time frame: 10 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Time frame: 10 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Time frame: 10 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Time frame: 10 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Time frame: 15 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Time frame: 15 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Time frame: 15 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Time frame: 15 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Time frame: 15 weeks to baseline
Non-verbal auditory testing: Pitch Change Detection task
Time frame: 20 weeks to baseline
Non-verbal auditory testing: Direction of pitch change identification task
Time frame: 20 weeks to baseline
Non-verbal auditory testing: Short term memory for pitch task
Time frame: 20 weeks to baseline
Non-verbal auditory testing: Emotional prosody recognition task
Time frame: 20 weeks to baseline
Non-verbal auditory testing: Auditory Streaming separation task
Time frame: 20 weeks to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Age-Related
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing Loss, Presbyacusis
Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
Hearing Loss, Age-Related, Presbycusis
Active, not recruiting
Hearing Healthcare Assessment in Rural Communities
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI)
Alzheimer Disease, Hearing Loss
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. This study is not recruiting at the moment.
agathe pralus, PhD study chair
Humans Matter
Questions about this trial
What is this clinical trial studying?
A study testing AUDISSEE in people with Hearing Loss, Age-Related, run by Humans Matter.
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 10 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact agathe pralus, PhD (+33611828004, a.pralus@humansmatter.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing in noise (time frame: 5 weeks to baseline). The study lists 8 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 28 Feb 2024.