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

NCT06656741 | Completed

• 2 other identifiers: NCTU-REC-109-037FMOST 110-2636-E007-018
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Breath Training Styles

Keywords

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

Outcome Measures

Primary Outcomes (4)

• EEG effective connectivity(dDTF)

  This 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.

  Through study completion, an average of 1 hour

• EEG connectivity inflow

  For a given EEG channel, the connectivity inflow represents the cumulative sum of all corresponding incoming connectivity edges.

  Through study completion, an average of 1 hour

• EEG connectivity outflow

  For a given EEG channel, the connectivity outflow represents the cumulative sum of all corresponding outgoing connectivity edges.

  Through study completion, an average of 1 hour

• EEG band power

  We 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).

  Through study completion, an average of 1 hour

Other Outcomes (9)

• EEG activity

  Through study completion, an average of 1 hour

• Breath rate

  Through study completion, an average of 1 hour

• Heart rate

  Through study completion, an average of 1 hour

Study Arms (1)

Single group

EXPERIMENTAL

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.

Behavioral: Resting State; Behavioral: Mindful Breathing; Behavioral: Guided Breathing; Behavioral: Breath Counting

Interventions

Resting State 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.

Single group

Mindful Breathing 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.

Single group

Guided Breathing 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).

Single group

Breath Counting 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.

Single group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hei-Yin Hydra Ng: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Tsing Hua University

Hsinchu, Hsinchu, 300193, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 35972793 BACKGROUND

• 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.

  PMID: 34860290 BACKGROUND

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

  PMID: 23777436 BACKGROUND

• 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.

  PMID: 39642375 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 24, 2024
• Study Start: May 11, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)