Clinical trial NCT06656741: Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance
Official title: Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance: an Extensive Exploration of EEG Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breath Training Styles
Keywords: bio-feedback
virtual reality
breath training
EEG
effective connectivity
Lead sponsor: National Tsing Hua University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2024-10-24
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 people's neuro-mechanism (indicated by EEG indexes) changes when they are performing different breath training techniques (i.e., 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 today's 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 training/mindfulness 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 training/mindfulness 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 people's neuro-mechanism (indicated by EEG indexes) changes when they are performing different breath training techniques (i.e., 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 NT$1,000.
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 participant's 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 (e.g., 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 \< 0.05.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged between 20 and 80.
2. Normal vision or corrected-to-normal vision.

Exclusion Criteria:

1. History of epilepsy, brain injury, or other neurological disorders in the individual or their family.
2. Long-term use of medication (e.g., antidepressants, sleep aids).
3. Claustrophobia.

Primary outcomes:
measure: EEG effective connectivity(dDTF)
timeFrame: Through study completion, an average of 1 hour
measure: EEG connectivity inflow
timeFrame: Through study completion, an average of 1 hour
measure: EEG connectivity outflow
timeFrame: Through study completion, an average of 1 hour
measure: EEG band power
timeFrame: Through study completion, an average of 1 hour
Secondary outcomes:
Other outcomes:
measure: EEG activity
timeFrame: Through study completion, an average of 1 hour
measure: Breath rate
timeFrame: Through study completion, an average of 1 hour
measure: Heart rate
timeFrame: Through study completion, an average of 1 hour
measure: Five Facet Mindfulness Questionnaire
timeFrame: 1 day
measure: Montreal Cognitive Assessment
timeFrame: 1 day
measure: Beck Depression Inventory
timeFrame: 1 day
measure: Beck Anxiety Inventory
timeFrame: 1 day
measure: Mind Wandering Questionnaire
timeFrame: 1 day
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 day
Locations:
city: Hsinchu
country: Taiwan
facility: National Tsing Hua University
Study officials:
References:
citation: Lukic YX, Teepe GW, Fleisch E, Kowatsch T. Breathing as an Input Modality in a Gameful Breathing Training App (Breeze 2): Development and Evaluation Study. JMIR Serious Games. 2022 Aug 16;10(3):e39186. doi: 10.2196/39186.
citation: Luddecke R, Felnhofer A. Virtual Reality Biofeedback in Health: A Scoping Review. Appl Psychophysiol Biofeedback. 2022 Mar;47(1):1-15. doi: 10.1007/s10484-021-09529-9. Epub 2021 Dec 3.
citation: Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.