Auditory Localization in Schizophrenia (LOCIZ)

May 7, 2025 updated by: Hôpital le Vinatier

Auditory Localization in Virtual Reality in Patients With a First Episode of Psychosis

Auditory sound localization is the ability to identify the position of a sound source in space. It is defined into 3 dimensions: by its position in azimuth, elevation and distance. If it is difficult to localize a sound source, it is possible to remove the localization ambiguity by interacting with the environment, in particular by changing one's position in relation to the source (e.g. by changing the orientation of the head).

Patients with schizophrenia have difficulties to localize and discriminate sounds in space but it is still poorly explored.

Additionally, deficits in auditory localization could underlie difficulties in source-monitoring (i.e., distinguish the source/origin of the information) reported in schizophrenia or deficits in auditory externalization (i.e., perception of sound outside the head).

Furthermore, schizophrenia is characterized by cerebral abnormalities in the auditory cortex, manifesting as auditory processing disorders at different stages of the pathology. Auditory localization may therefore be impaired from the onset of a first psychotic episode (FEP). This early phase of the disease is also referred to as the "critical" period, as the chances of remission are highest and the response to treatment is best. However, the three-dimensional aspect of auditory perception and the behavioral exploration strategies used to localize a sound in the early stages of schizophrenia are still little studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main objective of this study is to study the auditory localization performance on the horizontal and vertical planes (sound direction) in patients with a first episode psychosis (FEP) compared to healthy control subjects.

This study will:

  • evaluate the role of head movement on auditory localization abilities in patients with FEP compared with healthy control subjects;
  • evaluate the localization abilities of sounds in a noisy environment in patients with FEP compared with healthy control subjects;
  • evaluate the repercussions of poor auditory localization performance on the ability to distinguish between what comes from an internal source and what comes from an external source (source-monitoring abilities);
  • evaluate the repercussions of poor auditory localization performance on the ability to externalize an external auditory source compared with an internal source (auditory externalization abilities);
  • evaluate the relationships between auditory localization performance and auditory discrimination performance (pitch, volume, length);
  • evaluate the repercussions of the severity of symptoms in patients with FEP on auditory localization performance.

Subjects will undergo several auditory and cognitive tasks. The duration of the entire experiments will be 2.30 hours:

  • An auditory localization task in virtual reality with the SPHERE paradigm: the subject is immerged into a room and sounds are delivered through loudspeakers in different localization on the horizontal and vertical planes. Sounds are delivered in two experimental blocks: silent and noisy background. Each block is divided into two listening conditions: fixed head and active head movement (i.e., with the possibility of moving the head). Subjects have to localize each sound.
  • A source monitoring task divided into two parts: one part that will evaluate the reality-monitoring performances ('hear-imagine' task). Subjects either have to listen to words or imagine themselves listening to words; Another part evaluating internal source-monitoring performances ('say-imagine' task). Subjects either have to pronounce words or imagine themselves pronouncing words.
  • An auditory externalization task: Nonverbal sounds are delivered through headphones and processed to be perceived inside or outside the head. Subjects will have to discern whether a sound is perceived as coming from inside or outside the head.
  • A battery of psychoacoustic tests including the Tone Matching Task (TMT) which evaluates the capacity of discriminating static pitch.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bron, France, 69678
        • Centre Hospitalier Le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed of the study and having signed the consent form
  • With normal vision (with or without correction)
  • Able to understand the experimental instructions
  • Affiliated to the social security system
  • French language spoken, read and written

Exclusion Criteria:

  • Patients with a DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or brief psychotic disorder
  • Early intervention for first psychotic episodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient group with a first episode psychosis
Tasks will include an auditory localization task performed in virtual reality, a source-monitoring task, an externalization task and a battery of psychoacoustic tests.
Behavioral: cognitive experiments' session
The aim of this unique session of cognitive experiments is to study the auditory localization performance in patients with a first episode of psychosis. Results of this Arm 1 will be compared to those of Arm 2.
Active Comparator: Healthy control subjects
Tasks will include an auditory localization task performed in virtual reality, a source-monitoring task, an externalization task and a battery of psychoacoustic tests.
Behavioral: cognitive experiments' session
The aim of this unique session of cognitive experiments is to study the auditory localization performance in patients with a first episode of psychosis. Results of this Arm 1 will be compared to those of Arm 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Auditory localization performance in virtual reality
Time Frame: Baseline
an auditory localization task in virtual reality was design for this study. Sounds are presented in different localization on the horizontal and vertical planes. Participants performed two blocks (noise, silent background) divided into two conditions (localization with the fixed head or with the possibility of moving the head). Participants have to determine the localization of sound in space. The main outcome will be the perception performance corresponding to the directionality error (2Dd error in cm) in relation to the sound source.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The impact of head movements on auditory localization performance
Time Frame: Baseline
an auditory localization task in virtual reality was design for this study. Participants have to determine the localization of sounds in two different conditions: fixed head or with the possibility of moving the head. The main outcome will be the perception performance corresponding to the directionality error (2Dd error in cm) in the two different conditions.
Baseline
The impact of background noise on auditory localization performance
Time Frame: Baseline
an auditory localization task in virtual reality was design for this study. Participants have to determine the localization of sounds in two different blocks: silent and noisy background. The main outcome will be the perception performance corresponding to the directionality error (2Dd error in cm) in the two different blocks.
Baseline
Source-monitoring performance
Time Frame: Baseline
A computerized source memory task was designed for this study to assess the reality-monitoring (distinguishing real source and imagined source) and et internal source-monitoring (distinguishing two internal sources). The rate of correct responses and inversions are the outcome.
Baseline
Performance on auditory externalization
Time Frame: Baseline
computerized auditory externalization task. Nonverbal sounds are presented, the azimuth is varied in order to create the impression of the sound coming either from inside or outside the head. Subjects have to determine whether the nonverbal burst was perceived as coming from inside or outside their head. The rate of correct responses (inside/outside) is the outcome.
Baseline
Performance on basic auditory tasks
Time Frame: Baseline
a computerized psychoacoustic battery of tests : Tone Matching Task (evaluating nonverbal pitch). The rate of correct responses is the outcome.
Baseline
Performance on basic auditory tasks
Time Frame: Baseline
a computerized psychoacoustic battery of tests : psychoacoustic tasks measuring amplitude. The rate of correct responses is the outcome.
Baseline
Performance on basic auditory tasks
Time Frame: Baseline
a computerized psychoacoustic battery of tests : psychoacoustic tasks measuring length of sound . The rate of correct responses is the outcome.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital le Vinatier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frédéric HAESEBAERT, university professor, Hopital Le vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-A00469-40
  • PRVR06 (Other Grant/Funding Number: Centre Hospitalier le Vinatier)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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