Basic Auditory Processing and Auditory Hallucinations
AUDISCHIZ
1 other identifier
interventional
59
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Oct 2016
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
September 2, 2016
CompletedStudy Start
First participant enrolled
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedAugust 15, 2022
August 1, 2022
4.7 years
August 3, 2016
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage error in discrimination test psychoacoustic Tone Matching Task
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
Secondary Outcomes (1)
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
immediately after treatment
Study Arms (1)
30 patients with schizophrenia
EXPERIMENTALMeasure 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ch Le Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haesebaert Frédéric, PH
CH LE VINATIER
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
September 2, 2016
Study Start
October 6, 2016
Primary Completion
June 30, 2021
Study Completion
July 31, 2021
Last Updated
August 15, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share