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

NCT06921187 | Not Yet Recruiting

• 2 other identifiers: 2024-0582024-A02048-39
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Misophonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Measuring the consistency of the psychoacoustic test

  1 week after enrollement

• the number of redundant themes in the semi-structured interviews

  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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Behavioral: Psychoacoustic test; Other: semi-structured interviews

Misophonia group

EXPERIMENTAL

Behavioral: Psychoacoustic test; Other: semi-structured interviews; Other: Exposure to unpleasant sounds

Interventions

Psychoacoustic test BEHAVIORAL

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.

Control group; Misophonia group

semi-structured interviews OTHER

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

Control group; Misophonia group

Exposure to unpleasant sounds OTHER

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.

Misophonia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants
• Obtain oral consent from the participant after receiving information about the study,
• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead
• Institut de l'Audition: collaborator

Study Sites (2)

Centre de Recherche en Psychologie et Neuroscience (CRPN)

Marseille, 13003, France

Location

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, 75015, France

Location

MeSH Terms

Conditions

misophonia

Central Study Contacts

Arnaud Norena

CONTACT

+33488576863; arnaud.norena@univ-amu.fr

Paul Avan

CONTACT

paul.avan@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: exposure to unpleasant sounds at home is the focus of this study

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 10, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-03

Locations

FR (2)