NCT06974513

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress29%
Jun 2025Jun 2028

First Submitted

Initial submission to the registry

April 29, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

April 29, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

LocalizationAuditory perceptionSource monitoringVirtual reality

Outcome Measures

Primary Outcomes (1)

  • Auditory localization performance in virtual reality

    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 Outcomes (7)

  • The impact of head movements on auditory localization performance

    Baseline

  • The impact of background noise on auditory localization performance

    Baseline

  • Source-monitoring performance

    Baseline

  • Performance on auditory externalization

    Baseline

  • Performance on basic auditory tasks

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Patient group with a first episode psychosis

EXPERIMENTAL

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

Healthy control subjects

ACTIVE COMPARATOR

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

Interventions

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.

Healthy control subjectsPatient group with a first episode psychosis

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier le Vinatier

Bron, 69678, France

Location

Study Officials

  • Frédéric HAESEBAERT, university professor

    hopital le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydie SARTELET, Sponsor project manager

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 30 patients with a first episode psychosis and 30 healthy controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 16, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations