Biofeedback With Heart Sound Following Trauma

NCT06919055 | Recruiting

• 1 other identifier: ALLOSTAT0001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The Project aims to assess the long-term risk of trauma-induced stress in young persons. Using non-invasive sound therapy to assess the effects on the vagal nerve via cardiovascular effects and neural activity will provide biofeedback in these individuals.

Conditions

Young Earthquake Survivors

Keywords

biofeedback, trauma, allostasis

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  In order to carry out this study, the following basic measurements (gender, age, height, weight, blood pressure, etc.) and relative measurements from the basic measurements will be extracted. In this context, earthquake victims' cardiological, emotional, and psychological states will be observed through biomedical signals. From electrocardiogram (ECG), HRV, LF, HF, LF/HF, SDNN, and RMSSD parameters will be assessed to evaluate the autonomic nervous system, especially the parasympathetic nervous system. The fNIRS device will measure changes in oxygenated and deoxygenated hemoglobin concentration in the cortical structure of the forebrain, as well as markers of cardiovascular and psychological risk.

  2 months

Secondary Outcomes (1)

• Others biopotentials

  2 months

Study Arms (3)

control

ACTIVE COMPARATOR

no stimulation during mental stress

Other: Control-no treatment

PCG auditory stimulation group

EXPERIMENTAL

PCG auditory stimulation during mental stress

Other: PCG auditory stimulation

metronome in heart rhythm stimulation group

EXPERIMENTAL

MHR (or a metronome in heart rhythm) stimulation during mental stress

Other: MHR stimulation

Interventions

PCG auditory stimulation OTHER

PCG auditory stimulation during mental stress

PCG auditory stimulation group

MHR stimulation OTHER

MHR auditory stimulation during mental stress

metronome in heart rhythm stimulation group

Control-no treatment OTHER

no stimulation during mental stress

control

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• earthquake survivor university students between 20 and 25 will participate in the experiment. Participants will be healthy, non-obese men (n=15) and women (n=15). In particular, all participants should have experienced the earthquake disaster in the local region. All participants must be free of any chronic or acute infection, neurological, psychiatric, and/or cardiovascular disease.

You may not qualify if:

• They must be non-smokers, have no alcohol or drug addiction, and not be under any medical treatment. Pregnant or breastfeeding women will not be included in the study.

Sponsors & Collaborators

• Fatma Özcan: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Kahramanmaras

Kahramanmaraş, 46000, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Patron E, Calcagni A, Thayer JF, Scrimin S. The longitudinal negative impact of early stressful events on emotional and physical well-being: The buffering role of cardiac vagal development. Dev Psychobiol. 2021 Jul;63(5):1146-1155. doi: 10.1002/dev.22066. Epub 2020 Dec 11.

  PMID: 33314062 BACKGROUND

• Parizek D, Visnovcova N, Hamza Sladicekova K, Veternik M, Jakus J, Jakusova J, Visnovcova Z, Ferencova N, Tonhajzerova I. Effect of Selected Music Soundtracks on Cardiac Vagal Control and Complexity Assessed by Heart Rate Variability. Physiol Res. 2023 Nov 28;72(5):587-596. doi: 10.33549/physiolres.935114.

  PMID: 38015758 BACKGROUND

• Nakajima Y, Tanaka N, Mima T, Izumi SI. Stress Recovery Effects of High- and Low-Frequency Amplified Music on Heart Rate Variability. Behav Neurol. 2016;2016:5965894. doi: 10.1155/2016/5965894. Epub 2016 Aug 30.

  PMID: 27660396 BACKGROUND

• Lee SW, Laurienti PJ, Burdette JH, Tegeler CL, Morgan AR, Simpson SL, Gerdes L, Tegeler CH. Functional Brain Network Changes Following Use of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology for Military-Related Traumatic Stress. J Neuroimaging. 2019 Jan;29(1):70-78. doi: 10.1111/jon.12571. Epub 2018 Oct 10.

  PMID: 30302866 BACKGROUND

• Guannan, X., Xin, Z., Anchen, G., Siyang, H., Huijie, L., Jing, D., Qianqian, Z., & Jian, J. (2023). Phase-locked auditory pulse stimulation at home enhancing slow sleep waves: A pilot real-world study. medRxiv.

  BACKGROUND

• Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.

  PMID: 23532171 BACKGROUND

• Fioranelli M, Bottaccioli AG, Bottaccioli F, Bianchi M, Rovesti M, Roccia MG. Stress and Inflammation in Coronary Artery Disease: A Review Psychoneuroendocrineimmunology-Based. Front Immunol. 2018 Sep 6;9:2031. doi: 10.3389/fimmu.2018.02031. eCollection 2018.

  PMID: 30237802 BACKGROUND

• Adiasto K, Beckers DGJ, van Hooff MLM, Roelofs K, Geurts SAE. Music listening and stress recovery in healthy individuals: A systematic review with meta-analysis of experimental studies. PLoS One. 2022 Jun 17;17(6):e0270031. doi: 10.1371/journal.pone.0270031. eCollection 2022.

  PMID: 35714120 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Fatma Özcan

CONTACT

+905412385185; fatma.ozcan13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Lecturer

Model Details: Control group: 10 young 'healthy' earthquake survivors will not receive any auditory stimulation. 1. Intervention group: 10 young 'healthy' earthquake survivors will be subjected to a closed circuit, real-time heart sound (PCG) (to create biofeedback). 2. Intervention group: 10 young 'healthy' earthquake survivors will be given an auditory stimulus of their heart sound and average heart rate-MHR (or a metronome in heart rhythm) taken while calm.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 9, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)