Not yet recruitingNCT05848661AUDISSEEUpdated Feb 28, 2024

Evaluation of a Digital Therapy of Auditory Training

An interventional study of AUDISSEE and Placebo in Hearing Loss, Age-Related, sponsored by Humans Matter. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Humans Matter · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Hearing Loss, Age-Related

Browse trials for

Presbycusis 66

Keywords

Hearing aid
presbycusis
auditory training
hearing in noise

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 240 is above the median of 60 across 45 interventional studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Humans Matter is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
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

Exclusion criteria

Exclusion Criteria:

Age below 18
Pregnant or breastfeeding women

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Investigator, Outcomes assessor)
Enrollment: 240 participants (estimated)

Study arms

Experimental
AUDISSEE-verbal, AUDISSE-non-verbal, Placebo, Placebo
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
Device: AUDISSEE · Device: Placebo
Experimental
AUDISSE-non-verbal, AUDISSEE-verbal, Placebo, Placebo
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.
Device: AUDISSEE · Device: Placebo
Placebo comparator
Placebo, Placebo, AUDISSEE-verbal, AUDISSE-non-verbal
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.
Device: AUDISSEE · Device: Placebo
Placebo comparator
Placebo, Placebo, AUDISSE-non-verbal, AUDISSEE-verbal
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.
Device: AUDISSEE · Device: Placebo

Interventions

DeviceAUDISSEE
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.
DevicePlacebo
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.

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 weeks to baseline

Secondary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 20 weeks to baseline

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Mar 2025, 6 months later.

Of 25 interventional studies with no phase under Presbycusis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 22, 2023
First posted: May 8, 2023
StartEst.: Sep 2024
Primary completionEst.: Mar 2025
CompletionEst.: Mar 2025
Last update: Feb 28, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05848661
Lead sponsor: Humans Matter
Responsible party: Sponsor
First posted: May 8, 2023
Start date: Sep 2024 (estimated)
Primary completion: Mar 2025 (estimated)
Completion: Mar 2025 (estimated)
Last update: Feb 28, 2024

Study contacts

agathe pralus, PhD

Contact

a.pralus@humansmatter.co

+33611828004

agathe pralus, PhD

study chair · Humans Matter

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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