Basic Auditory Processing and Auditory Hallucinations

Schizophrenia Clinical Trial

— AUDISCHIZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887794
• Other study ID #: 2016-A00141-50
• Status: Completed
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2022
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 65 years old

• Meeting DSM-5.0 criteria for schizophrenia

• Auditory Hallucinations Rating Scale = 8

• Negative ßHCG 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

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

Other:
• Clinical and psychoacoustic measures
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

Locations

Country	Name	City	State
France	Ch Le Vinatier	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	immediately after treatment