Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656741
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance an Extensive Exploration of EEG Markers
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research is to learn about the neuro-mechanism beneath breath training mindfulness meditation or periods of idleness This research also focuses on the use of virtual reality VR and bio-feedback BF integrated assistance system in breath training and seeks for the potential of generalizing breath training in public
The main questions it aims to answer are
Whether and how peoples neuro-mechanism indicated by EEG indexes changes when they are performing different breath training techniques ie mindful breathing guided breathing and breath counting
Researchers will compare the neuro-markers when participants perform different styles of breath training
Participants will
Participants will equip an EEG system a VR headset a respiratory belt and a heartbeat sensor
Participants will perform resting state task mindful breathing task guided breath task and breath counting task respectively
EEG activity breath rate reaction time accuracy and HRV will be recorded Each session will last approximately two hours
The main questions it aims to answer are
Whether and how peoples neuro-mechanism indicated by EEG indexes changes when they are performing different breath training techniques ie mindful breathing guided breathing and breath counting
Researchers will compare the neuro-markers when participants perform different styles of breath training
Participants will
Participants will equip an EEG system a VR headset a respiratory belt and a heartbeat sensor
Participants will perform resting state task mindful breathing task guided breath task and breath counting task respectively
EEG activity breath rate reaction time accuracy and HRV will be recorded Each session will last approximately two hours
Detailed Description:
1 Research Overview In todays fast-paced industrial society managing individual physical and psychological stress has become crucial for maintaining mental emotional and brain health Practices such as breath training mindfulness meditation or periods of idleness have been suggested as effective means to relieve stress reduce anxiety and improve sleep quality This study combines cognitive psychology behavioral measurements electroencephalography EEG and heart rate variability HRV to investigate the cognitive function brain structure and brain activity of adults with breath trainingmindfulness meditation experience or regular episodes of mind-wandering Meanwhile this research also focuses on the use of technology namely virtual reality VR and bio-feedback BF integrated assistance system and seeks for the potential of generalizing breath training in public By utilizing non-invasive neuroimaging techniques this research aims to provide scientific evidence regarding the effects of breath trainingmindfulness meditation and mind-wandering Ultimately the study seeks to apply these findings to improve national mental and brain health
The research questions are whether and how peoples neuro-mechanism indicated by EEG indexes changes when they are performing different breath training techniques ie mindful breathing guided breathing and breath counting
2 Research Participants Age range 20-80 years old Total 53 participants
Withdrawal Criteria
Participants can withdraw at any point if they feel discomfort
3 Compensation for Participation Participants will receive a total of NT1000
4 Informed Consent Process The research personnel will explain the study to participants at the study locations The informed consent process will take approximately 30 minutes per participant
5 Potential Side Effects Follow-Up Procedures and Necessary Rehabilitation Plans
1 Physiological Risks
Electroencephalography EEG EEG measures brain activity passively from the scalp using a non-invasive method that does not involve electrical discharge or radiation thus posing no harm to participants During the application of conductive gel with blunt needles the needles may touch the scalp but will not cause any damage All needles are sterilized with alcohol before use Participants are encouraged to notify the experimenter immediately if any discomfort arises The gel will remain on the participants scalp throughout the experiment and electrodes around the eyes will be affixed using breathable medical tape For individuals with sensitive skin mild itching may occur although no allergic reactions have been reported
2 Psychological Risks
There is a minimal risk of psychological discomfort during the study Participants may discontinue the experiment at any time if they feel uncomfortable
3 Social Risks
Participants may face minimal social risks but the research team will make every effort to protect their privacy and confidentiality in accordance with legal requirements
6 Privacy and Data Confidentiality
1 All collected data and samples will be securely locked and electronic data will be stored on password-protected systems
2 Data Preservation and Confidentiality
Participant data including names and other identifiable information will be coded or anonymized eg using initials
The de-identification method will ensure that no linkages to identifiable information can be made in the future
3 Handling of Remaining Samples and Confidential Data After Study Completion
Identifiable data will be destroyed by the principal investigator five years after the study ends December 31 2028
EEG data will be anonymized and preserved for future research with all identifiable links permanently removed No identifying information will appear in any published academic articles
7 Research Procedures This cross-sectional study will use various cognitive psychology paradigms and EEG to examine cognitive function brain activity and structure in adults Participants will complete self-report questionnaires regarding their mental and physiological states
Participants will equip an EEG system a VR headset a respiratory belt and a heartbeat sensor Participants will perform resting state task mindful breathing task guided breath task and breath counting task respectively with the sequence counter-balanced EEG activity breath rate reaction time accuracy and HRV will be recorded Each session will last approximately two hours
8 Evaluation and Statistical Methods EEG data will be analyzed using MATLAB and SPM Statistical Parametric Mapping with statistical analyses performed in SPSS Brain activation and structural data will be evaluated and ANOVA will be applied to questionnaires and behavioral data Relationships between behavioral and neural measures will be examined and statistical significance will be determined at p 005
The research questions are whether and how peoples neuro-mechanism indicated by EEG indexes changes when they are performing different breath training techniques ie mindful breathing guided breathing and breath counting
2 Research Participants Age range 20-80 years old Total 53 participants
Withdrawal Criteria
Participants can withdraw at any point if they feel discomfort
3 Compensation for Participation Participants will receive a total of NT1000
4 Informed Consent Process The research personnel will explain the study to participants at the study locations The informed consent process will take approximately 30 minutes per participant
5 Potential Side Effects Follow-Up Procedures and Necessary Rehabilitation Plans
1 Physiological Risks
Electroencephalography EEG EEG measures brain activity passively from the scalp using a non-invasive method that does not involve electrical discharge or radiation thus posing no harm to participants During the application of conductive gel with blunt needles the needles may touch the scalp but will not cause any damage All needles are sterilized with alcohol before use Participants are encouraged to notify the experimenter immediately if any discomfort arises The gel will remain on the participants scalp throughout the experiment and electrodes around the eyes will be affixed using breathable medical tape For individuals with sensitive skin mild itching may occur although no allergic reactions have been reported
2 Psychological Risks
There is a minimal risk of psychological discomfort during the study Participants may discontinue the experiment at any time if they feel uncomfortable
3 Social Risks
Participants may face minimal social risks but the research team will make every effort to protect their privacy and confidentiality in accordance with legal requirements
6 Privacy and Data Confidentiality
1 All collected data and samples will be securely locked and electronic data will be stored on password-protected systems
2 Data Preservation and Confidentiality
Participant data including names and other identifiable information will be coded or anonymized eg using initials
The de-identification method will ensure that no linkages to identifiable information can be made in the future
3 Handling of Remaining Samples and Confidential Data After Study Completion
Identifiable data will be destroyed by the principal investigator five years after the study ends December 31 2028
EEG data will be anonymized and preserved for future research with all identifiable links permanently removed No identifying information will appear in any published academic articles
7 Research Procedures This cross-sectional study will use various cognitive psychology paradigms and EEG to examine cognitive function brain activity and structure in adults Participants will complete self-report questionnaires regarding their mental and physiological states
Participants will equip an EEG system a VR headset a respiratory belt and a heartbeat sensor Participants will perform resting state task mindful breathing task guided breath task and breath counting task respectively with the sequence counter-balanced EEG activity breath rate reaction time accuracy and HRV will be recorded Each session will last approximately two hours
8 Evaluation and Statistical Methods EEG data will be analyzed using MATLAB and SPM Statistical Parametric Mapping with statistical analyses performed in SPSS Brain activation and structural data will be evaluated and ANOVA will be applied to questionnaires and behavioral data Relationships between behavioral and neural measures will be examined and statistical significance will be determined at p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None