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Completed

NCT Number: NCT02887794

Basic Auditory Processing and Auditory Hallucinations

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.

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Key information

Conditions

Schizophrenia Auditory Diseases, Central Auditory Perceptual Disorders Brain Diseases Central Nervous System Diseases Cognition Disorders Ear Diseases Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Perceptual Disorders Retrocochlear Diseases Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical and psychoacoustic measures

Other

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 outcomes

  1. percentage error in discrimination test psychoacoustic Tone Matching Task

    Time frame: 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.

Secondary outcomes

  1. Score the item hallucinations of psychometric ( positive and negative syndrome ) scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: AUDISCHIZ

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2016
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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