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

NCT ID: NCT06656741

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2022-03-31

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.

Conditions

Breath Training Styles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single group

This is a single group study. All participants belong to this group. Participants will perform resting state task, mindful breathing task, guided breath task, and breath counting task respectively. The task sequence is counter-balanced.

Group Type: EXPERIMENTAL

Resting State

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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).

Breath Counting

Intervention Type: BEHAVIORAL

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.

Interventions

Resting 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.

Intervention Type: BEHAVIORAL

Mindful Breathing

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.

Intervention Type: BEHAVIORAL

Guided Breathing

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).

Intervention Type: BEHAVIORAL

Breath 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Hei-Yin Hydra Ng

OTHER

Sponsor Role: lead

Responsible Party

Hei-Yin Hydra Ng

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

National Tsing Hua University

Hsinchu, Hsinchu, Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 35972793 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34860290 (View on PubMed)

Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.

Reference Type: BACKGROUND

PMID: 23777436 (View on PubMed)

Ng HH, Wu CW, Hsu HC, Huang CM, Hsu AL, Chao YP, Jung TP, Chuang CH. Neurological Evidence of Diverse Self-Help Breathing Training With Virtual Reality and Biofeedback Assistance: Extensive Exploration Study of Electroencephalography Markers. JMIR Form Res. 2024 Dec 6;8:e55478. doi: 10.2196/55478.

Reference Type: DERIVED

PMID: 39642375 (View on PubMed)

Other Identifiers

MOST 110-2636-E007-018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCTU-REC-109-037F

Identifier Type: -

Identifier Source: org_study_id