Evaluation of a Digital Therapy of Auditory Training

NCT05848661 | Not Yet Recruiting

• 1 other identifier: 2023-A00248-37
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hearing Loss, Age-Related

Keywords

Hearing aid; presbycusis; auditory training; hearing in noise

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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

  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

  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

  20 weeks to baseline

Secondary Outcomes (32)

• Quality of life and hearing : personal efficacy

  5 weeks to baseline

• Quality of life and hearing : listening effort

  5 weeks to baseline

• Quality of life and hearing : spatial learning abilities

  5 weeks to baseline

• Quality of life and hearing: personal efficacy

  10 weeks to baseline

• Quality of life and hearing: listening effort

  10 weeks to baseline

Study Arms (4)

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

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.

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.

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.

Device: AUDISSEE; Device: Placebo

Interventions

AUDISSEE DEVICE

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.

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

Placebo DEVICE

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.

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Age below 18
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Humans Matter: lead

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

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

Study Officials

• agathe pralus, PhD

  Humans Matter

  STUDY CHAIR

Central Study Contacts

agathe pralus, PhD

CONTACT

+33611828004; a.pralus@humansmatter.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The training will be performed at home. The investigators/evaluators will send a download link of the therapy to the patients without knowing which therapy it corresponds to.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 8, 2023
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share