NCT02887794

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

4.7 years

First QC Date

August 3, 2016

Last Update Submit

August 11, 2022

Conditions

Keywords

pitch discriminationauditory processing disordersauditory perceptionauditory-verbal hallucinationstheory of mind

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

EXPERIMENTAL

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.

Other: Clinical and psychoacoustic measures

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

30 patients with schizophrenia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

SchizophreniaAuditory Perceptual DisordersHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersAuditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive Disorders

Study Officials

  • Haesebaert Frédéric, PH

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

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

Locations