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Basic Auditory Processing and Auditory Hallucinations (AUDISCHIZ)

11. august 2022 opdateret af: Hôpital le Vinatier

Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study

Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Outcomes: Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test. The main objective is to assess this correlation. Our other objectives are to assess correlation between AHRS as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities. Impact of therapeutic procedures (neuromodulation, psychotherapy) conducted independently of our study on these psychoacoustic tests will also be assessed.

Methods: 30 subjects with schizophrenia will be included. Clinical and psychoacoustic measures will be carried out at J-0. In the case of patients receiving therapeutic procedures independently of our study, new clinical and psychoacoustic measures will be carried out at J+7 and J+30.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rhone Alpes
      • Lyon, Rhone Alpes, Frankrig, 69678
        • CH Le Vinatier

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age from 18 to 65 years old
  • Meeting DSM-5.0 criteria for schizophrenia
  • Auditory Hallucinations Rating Scale ≥ 8
  • Negative βHCG level if woman
  • Effective contraception if woman
  • Consent to be included in the study

Exclusion Criteria:

  • Hearing impairment
  • Neurologic disorder
  • Other psychiatric disorder from the DSM-5.0 section II
  • Developed musical abilities (regular practice of singing or a musical instrument)
  • Pregnancy
  • Does not consent to be included in the study
  • Lacking in legal capacity

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 30 patients with schizophrenia
Measure the correlation between the score on the scale psychometric AHRS (Auditory Hallucination Rating Scale) to measure HAV and performance scores discrimination test psychoacoustic Tone Matching Task in subjects suffering from schizophrenia and HAV.
Our study focuses on psychoacoustic tests, specialist care protocols (psychotherapy, neuromodulation ...) being made independently of our study, as part of medical activity of Cerletti care unit or differentiated protocols. Thus, our study shows no individual benefit for the patient. However, a better understanding of the neurophysiological mechanisms underlying auditory hallucinatory phenomenon could allow a better management of these patients in the near future

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
percentage error in discrimination test psychoacoustic Tone Matching Task
Tidsramme: immediately after treatment
Our main hypothesis is that Auditory Hallucinations Rating Scale (AHRS) scores are correlated with the percentage of wrong answers in a Tone-Matching Task test.
immediately after treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
Tidsramme: immediately after treatment
Rating Scale(AHRS) as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities.
immediately after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Haesebaert Frédéric, PH, CH Le Vinatier

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. oktober 2016

Primær færdiggørelse (Faktiske)

30. juni 2021

Studieafslutning (Faktiske)

31. juli 2021

Datoer for studieregistrering

Først indsendt

3. august 2016

Først indsendt, der opfyldte QC-kriterier

29. august 2016

Først opslået (Skøn)

2. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Clinical and psychoacoustic measures

3
Abonner