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Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance

Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance: an Extensive Exploration of EEG Markers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06656741
Enrollment
53
Registered
2024-10-24
Start date
2021-05-11
Completion date
2022-03-31
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breath Training Styles

Keywords

bio-feedback, virtual reality, breath training, EEG, effective connectivity

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.

Interventions

BEHAVIORALResting State

Resting state is a mental state and a research paradigm that people do nothing and idle as much as possible to show their baseline neuro signals. In this task, we instructed participants to rest with their eyes opened for 6 minutes. The VR environment of blue sky and swaying meadow was presented to the participants throughout this task.

Mindful breathing is a state that people focus on their inner sensation. In this task, the meadow's motion in the VR environment corresponded to the participants' inhalation and exhalation, as detected by the respiration belt. The participants were instructed to focus mentally on their bodily sensations as they breathed, with the meadow's sway as a visual cue.

Guided breathing refers to the breath training technique that trainees are guided to inhale and exhale according to a fixed tempo. In this task, meadow swayed in a fixed tempo of 4 seconds back and 6 seconds forth. The participants were instructed to synchronize their inhalation with the meadow's backward motion (lasting 4 seconds) and their exhalation with its forward motion (lasting 6 seconds).

BEHAVIORALBreath Counting

Breath counting refers to the breath training technique that trainees mentally count the numbers of breath cycles they have finished in a certain period of time. In this task, similar to the mindful breathing task, the meadow's motion was synchronized with the participants' breathing patterns. During the 6 minutes, we instructed the participants to breathe naturally and mentally count their breathing cycles.

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Hei-Yin Hydra Ng
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
EEG effective connectivity(dDTF)Through study completion, an average of 1 hourThis study employed the direct directed transfer function (dDTF) to evaluate causal relationships between EEG channels. Modified from the directed transfer function, the dDTF is an effective connectivity estimator grounded in frequency-domain Granger causality. The dDTF isolates and assesses the direct causal link between a specific pair of channels, effectively mitigating the impact of indirect neural influences because of brain tissue conductivity.
EEG connectivity inflowThrough study completion, an average of 1 hourFor a given EEG channel, the connectivity inflow represents the cumulative sum of all corresponding incoming connectivity edges.
EEG connectivity outflowThrough study completion, an average of 1 hourFor a given EEG channel, the connectivity outflow represents the cumulative sum of all corresponding outgoing connectivity edges.
EEG band powerThrough study completion, an average of 1 hourWe converted the EEG data to a frequency-domain signal using a short-time Fourier transformation. All transformed spectra were then log-transformed and represented in dB (10log10).

Other

MeasureTime frameDescription
Montreal Cognitive Assessment1 dayMontreal Cognitive Assessment (MoCA) is a questionnaire for the early detection of mild cognitive impairment. MoCA consists of 30 items, and the score ranges between 0 and 30. The higher score represents the better cognitive function.
Beck Depression Inventory1 dayBeck Depression Inventory (BDI) is a self-report measure of people's symptoms of depression. BDI consists of 21 items, and the score ranges between 0 to 21. The higher score represents the higher depression level.
EEG activityThrough study completion, an average of 1 hourA Brain Products GmbH 32-channel LiveAmp EEG system (Gilching, Germany) was used to collect the EEG data at a sampling rate of 1,000 Hz and a resolution of 40.7 nV. We mounted the electrodes on a Brain Products EasyCap (Gilching, Germany), the layout of which followed the international 10/20 electrode placement system. The electrode-skin impedance was maintained under 10 kΩ with an abrasive electrode paste (Abralyt HiCl). EEG data on all channels were acquired using FCz as the reference and were filtered using a band-pass filter of 0.0159 Hz and 250 Hz, plus a 60 Hz notch filter.
Mind Wandering Questionnaire1 dayMind Wandering Questionnaire measures people's frequency of mind-wandering. It consists of 5 items, the score ranges between 1 and 30. The higher score represents more frequent mind-wandering.
Pittsburgh Sleep Quality Index1 dayPittsburgh Sleep Quality Index (PSQI) is a self-report measurement of people's sleep difficulty. It consists of 9 items, the score ranges between 1 and 21. The higher score represents the higher level of sleep difficulty.
Beck Anxiety Inventory1 dayBeck Anxiety Inventory (BAI) is a self-report measure of people's symptoms of anxiety. BAI consists of 21 items, the score ranges between 0 to 21. The higher score represents the higher anxiety level.
Breath rateThrough study completion, an average of 1 hourA Vernier Go Direct® Respiration Belt (Beaverton, Oregon, U.S.) monitored and captured the respiration data at a sampling rate of 1,000 Hz. The respiration belt was worn on the rib cage. After the initiation of each experimental condition (i.e., each breathing technique), the program collected 10 seconds of a respiratory signal from each participant for normalization. We compared the respiratory signal with the normalized signal to determine whether the participant was inhaling or exhaling.
Heart rateThrough study completion, an average of 1 hourThe ArtiseBio Cygnus-819997-RawEEG system (Hsinchu, Taiwan) was employed to collect ECG data at a sampling rate of 1,000 Hz. Three electrodes from the ArtiseBio system were affixed to Kendall 200 series electrode pads (Cardinal Health, Dublin, Ohio, U.S.) and positioned according to the standard limb leads II configuration for heart rate monitoring.
Five Facet Mindfulness Questionnaire1 dayFive Facet Mindfulness Questionnaire (FFMQ) is measure of people's mindfulness level. FFMQ consists of 39 items, and the score ranges between 1 and 39. The higher score represents the higher mindfulness level.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026