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NCT Number: NCT06921187

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

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.

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Key information

Conditions

Misophonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche en Psychologie et Neuroscience (CRPN), Marseille, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)

    Time frame: 1 week after enrollment

    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

  2. score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)

    Time frame: 1 week after enrollment

    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

Secondary outcomes

  1. Measuring the consistency of the psychoacoustic test

    Time frame: 1 week after enrollement

    consistency measured by calculating Cronbach's alpha coefficient

  2. the number of redundant themes in the semi-structured interviews

    Time frame: 1 month after enrollment

    the interviews consist of open-ended questions covering different aspects of the experiences of misophone subjects

  3. score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)

    Time frame: 1 month after enrollment and 2 months after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Arnaud Norena

CONTACT

[email protected]

+33488576863

Paul Avan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Institut de l'Audition

Registry information

Official study title

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

Acronym: PROMISE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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