- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07857239
Stress Through Audition: Uptake, Recovery, Oscillations During Nature Exposure (SAURON)
A Stress Study Through Auditory Soundscapes: Uptake, Recovery and Cerebral Oscillations During Nature Versus Urban Exposure
The protocol the investigators propose aims to address certain gaps by developing a multimodal paradigm, based on:
- Induction of acute stress via the Maastricht Acute Stress Test (MAST), a standardised protocol recognised for its effectiveness in activating both the HPA axis and the autonomic nervous system.
- A 10-minute auditory exposure to two types of soundscapes (natural vs urban), designed in accordance with ecological standards (recordings taken from real-world environments and featuring representative natural and anthropogenic sound components, with the aim of making the stimulus as close as possible to real-life experiences).
- A battery of synchronised, multimodal measurements, including hormonal measurements (salivary cortisol at 10 time points), continuous autonomic nervous system measurements (HR, HRV, BP), a high-density EEG and analysis via EEG Source Imaging (ESI), a battery of cognitive tests typically sensitive to stress (Continuous Visual Attention Task, N-back, Delay Discounting Task), and a light polysomnography study conducted at home to assess delayed effects on sleep.
This design will enable the investigators to examine, as comprehensively as possible, the dynamics of post-stress recovery across several levels of analysis (biological, cerebral, cognitive and behavioural). It will also enable the investigators to identify the specific effects of the sound environment on each of these levels. By cross-referencing neurophysiological, hormonal and behavioural responses, we hope to document how natural sound environments actively regulate stress and cognition and to explore the mechanisms involved.
This project could pave the way for applications in mental health, preventive neuroscience, acoustic urban planning and non-pharmacological interventions, by providing a rigorous scientific foundation to support recommendations for the design or management of stress in professional, educational or clinical settings.
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Frédéric Pr Frédéric Haesebaert, PhD
- Telefonszám: +33 (0)4 37 91 55 34
- E-mail: frederic.haesebaert@ch-le-vinatier.fr
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Jérôme Dr Jérôme BRUNELIN
- Telefonszám: +33 (0)4 37 91 55 65
- E-mail: jerome.brunelin@ch-le-vinatier.fr
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Men and women between 18 and 45 years of age inclusive;
- Informed about the study and having signed the consent form;
- With normal vision (with or without correction);
- Able to understand the experimental instructions;
- Covered by the French social security system;
- Proficient in spoken, read, and written French.
Exclusion Criteria:
- Having a vision or hearing impairment that could prevent the proper performance of tasks involving reading on a screen or paper and listening to auditory stimuli;
- Being a smoker;
- Having a somatic condition, particularly a neurological or endocrine disorder, or a circulatory disorder in the extremities (Raynaud's disease);
- Having or having had a personal or first-degree family history of diagnosed psychiatric disorders (according to Axis 1 of the criteria in the Diagnostic and Statistical Manual of Mental Disorders - DSM-5);
- Taking medication (except for oral contraceptives);
- Being pregnant or breastfeeding;
- Being under a protective measure (guardianship, conservatorship, protective order, etc.)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Participants exposed to the natural soundscape
Participants undergo the Maastricht Acute Stress Test (MAST) to induce acute stress, followed by a 10-minute auditory exposure to a standardized natural soundscape delivered via headphones. Physiological (cortisol, HR, HRV, BP), cerebral (high-density EEG with source imaging), and cognitive measures are collected before and after the stress induction and the soundscape exposure. |
10-minute passive auditory exposure to a standardized natural soundscape assembled from real-world recordings normalized and characterized. Delivered via headphones in a seated, resting position immediately following MAST-induced acute stress. Single administration per participant |
|
Aktív összehasonlító: Participants exposed to the urban soundscape
Participants undergo the Maastricht Acute Stress Test (MAST) to induce acute stress, followed by a 10-minute auditory exposure to a standardized urban soundscape delivered via headphones. Physiological (cortisol, HR, HRV, BP), cerebral (high-density EEG with source imaging), and cognitive measures are collected before and after the stress induction and the soundscape exposure. |
10-minute passive auditory exposure to a standardized urban soundscape assembled from real-world recordings normalized and characterized. Delivered via headphones in a seated, resting position immediately following MAST-induced acute stress. Single administration per participant. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in salivary cortisol concentration following acute stress and a natural soundscape exposure.
Időkeret: Day 1
|
Salivary cortisol will be measured as a biological marker of hypothalamic-pituitary-adrenal (HPA) axis activation, in response to an acute stress induction (MAST) followed by a 10-minute auditory exposure to a natural soundscape. |
Day 1
|
|
Change in salivary cortisol concentration following acute stress and an urban soundscape exposure.
Időkeret: Day 1
|
Salivary cortisol will be measured as a biological marker of hypothalamic-pituitary-adrenal (HPA) axis activation, in response to an acute stress induction (MAST) followed by a 10-minute auditory exposure to an urban soundscape. |
Day 1
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Post-stress cognitive performance across sustained attention task for the urban soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the Continuous Visual Attention Task (CVAT, sustained attention) for the urban soundscape arm. |
Day 1
|
|
Post-stress cognitive performance across sustained attention task for the natural soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the Continuous Visual Attention Task (CVAT, sustained attention) for the natural soundscape arm. |
Day 1
|
|
Post-stress cognitive performance across working memory task for the urban soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the N-back task (working memory) for the urban soundscape arm. |
Day 1
|
|
Post-stress cognitive performance across working memory task for the natural soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the N-back task (working memory) for the natural soundscape arm. |
Day 1
|
|
Post-stress cognitive performance across decision-making task for the urban soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the Delay Discounting Task (decision-making) for the urban soundscape arm. |
Day 1
|
|
Post-stress cognitive performance across decision-making task for the natural soundscape arm.
Időkeret: Day 1
|
Cognitive performance assessed via computerized task: the Delay Discounting Task (decision-making) for the natural soundscape arm. |
Day 1
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- PRVT-03
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