Basic Auditory Processing and Auditory Hallucinations (AUDISCHIZ)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and psychoacoustic measures
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring pitch discrimination, auditory processing disorders, auditory perception, auditory-verbal hallucinations, theory of mind
Eligibility Criteria
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
Sites / Locations
- Ch Le Vinatier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
30 patients with schizophrenia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
Rating Scale(AHRS) as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02887794
Brief Title
Basic Auditory Processing and Auditory Hallucinations
Acronym
AUDISCHIZ
Official Title
Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2016 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
pitch discrimination, auditory processing disorders, auditory perception, auditory-verbal hallucinations, theory of mind
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 patients with schizophrenia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical and psychoacoustic measures
Intervention Description
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
Primary Outcome Measure Information:
Title
percentage error in discrimination test psychoacoustic Tone Matching Task
Description
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.
Time Frame
immediately after treatment
Secondary Outcome Measure Information:
Title
Score the item hallucinations of psychometric ( positive and negative syndrome ) scale
Description
Rating Scale(AHRS) as well as other symptoms scales and psychoacoustic tests assessing intensity, length discrimination of non-verbal tones and self-monitoring abilities.
Time Frame
immediately after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haesebaert Frédéric, PH
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Le Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Basic Auditory Processing and Auditory Hallucinations
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