Study of Auditory Perception After Progressive Exposure to Aversive Sounds in People With Misophonia (PROMISE)

Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs

The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Misophonia
• Intervention / Treatment: Behavioral: Psychoacoustic test; Other: semi-structured interviews; Other: Exposure to unpleasant sounds

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud Norena; Phone Number: +33488576863; Email: arnaud.norena@univ-amu.fr
• Study Contact Backup: Name: Paul Avan; Email: paul.avan@pasteur.fr

Study Locations

• France
  • Marseille, France, 13003
    • Centre de Recherche en Psychologie et Neuroscience (CRPN)
    • Contact: Arnaud Norena; Phone Number: +33488576863; Email: arnaud.norena@univ-amu.fr
  • Paris, France, 75015
    • CEntre de Recherche et d'Innovation en Audiologie Humaine
    • Contact: Paul Avan; Phone Number: +331 76 53 50 93; Email: paul.avan@pasteur.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For all participants

• Obtain oral consent from the participant after receiving information about the study,
• Be 18 years or older on the day of inclusion,
• Be fluent in French (spoken and written),
• Have no known hearing loss, verified by pure tone audiometry.
• Declare that they do not have tinnitus,
• Declare that they do not have hyperacusis, verified by measuring discomfort thresholds.
• Be affiliated to the social security or equivalent scheme.

For participants with misophonia:

- Declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.).

Exclusion Criteria:

• Bear the after-effects of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
• Be under guardianship,
• deprived of liberty by judicial or administrative decision, or subject to legal protection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Psychoacoustic test; Natural sounds will be presented at different decibels (dB), and the subject will be asked to rate the pleasantness/unpleasantness of the sound heard on a visual analogue scale, as well as the loudness (subjective intensity) of the sound heard.; Other: semi-structured interviews; interview, designed under the supervision of a psychologist and using the methodology of micro-phenomenological interviews the aim of these interviews is to gain access to the participants' experiences, as they describe them in the first person, during misophonic episodes
Experimental: Misophonia group	Behavioral: Psychoacoustic test; Natural sounds will be presented at different decibels (dB), and the subject will be asked to rate the pleasantness/unpleasantness of the sound heard on a visual analogue scale, as well as the loudness (subjective intensity) of the sound heard.; Other: semi-structured interviews; interview, designed under the supervision of a psychologist and using the methodology of micro-phenomenological interviews the aim of these interviews is to gain access to the participants' experiences, as they describe them in the first person, during misophonic episodes; Other: Exposure to unpleasant sounds; Home exposure is a practice whereby participants voluntarily subject themselves to SMs in a controlled environment. Participants will be asked to complete two tasks: firstly, they will have to expose themselves to all 10 sounds at least twice a week; secondly, they will have to record the annoyance felt for each sound and the subjective loudness (loudness) of each SM using VAS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)	sounds will be presented at different decibels and the subject will be asked to rate the pleasantness/unpleasantness of the sound on a visual analogue scale	1 week after enrollment
score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)	sounds will be presented at different decibels and the subject will be asked to rate the intensity of the sound on a visual analogue scale	1 week after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the consistency of the psychoacoustic test	consistency measured by calculating Cronbach's alpha coefficient	1 week after enrollement
the number of redundant themes in the semi-structured interviews	the interviews consist of open-ended questions covering different aspects of the experiences of misophone subjects	1 month after enrollment
score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)		1 month after enrollment and 2 months after enrollment

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: Institut de l'Audition

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-058; 2024-A02048-39 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No