Phenotypic Exploration During Sensory Stimulation in an A... | NCT07544563

Studies
Phenotypic Exploration During Sensory Stimulation in an Acoustic Chamber

NCT07544563

Sponsor

Centre Hospitalier St Anne

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Epilepsy
Anxiety
Depression Anxiety Disorder

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2025Actual

Primary Completion Date

Dec 2, 2035Estimated

Completion Date

Dec 2, 2035Estimated

First Submitted Date

Apr 3, 2026

First Submission Date that Met QC Criteria

Apr 15, 2026

First Posted Date

Apr 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An observational behavioural and neurophysiological study of the effects of controlled sensory stimulation (such as music, for example) on brain function

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epilepsy and music		Epileptic patients (with or without mood disorders) exposed to music stimulations

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuronal networks	Description of the neural networks involved during exposure to sensory stimuli	All along the study (8 years)

Secondary Outcomes

Measure	Description	Time Frame
Psychologic outcome : anxiety	Assessment of the Generalized Anxiety Disorder-7 (GAD7) in the exposed patients across the hospitalization : minimum value 0; maximum 21; higher scores mean a worse outcome	8 years
Psychologic outcome 2 : depression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For patients : epilepsy
For healthy volunteers: age > 18 yo

Exclusion Criteria:

For patients and healthy volonteers : Deafness
For healthy volunteers : History of neurological conditions (including stroke, coma, epilepsy, neuro-inflammatory or neurodegenerative disease) or diagnosed cognitive impairment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

GHU paris Sainte Anne

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Viviane AWASSI	Contact	+33145658486		v.awassi@ghu-paris.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GHU Paris Sainte Anne	Recruiting	Paris		75014	France

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided