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Not yet recruiting NCT06921187

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

No phase Interventional Misophonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychoacoustic test, semi-structured interviews, Exposure to unpleasant sounds.
Who it may be relevant to
Registry conditions: Misophonia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound) [Time frame: 1 week after enrollment]
  • score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense) [Time frame: 1 week after enrollment]
Secondary outcome measures (3)
  • Measuring the consistency of the psychoacoustic test [Time frame: 1 week after enrollement]
  • the number of redundant themes in the semi-structured interviews [Time frame: 1 month after enrollment]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 2 centers
  • Centre de Recherche en Psychologie et Neuroscience (CRPN) — Marseille
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Identifiers

NCT: NCT06921187 · 2024-058 · 2024-A02048-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗