National Tsing Hua University
Hsinchu, 300193, Taiwan
NCT Number: NCT06656741
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.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Hsinchu, 300193, Taiwan
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).
Withdrawal Criteria:
Participants can withdraw at any point if they feel discomfort.
There is a minimal risk of psychological discomfort during the study. Participants may discontinue the experiment at any time if they feel uncomfortable.
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: Through study completion, an average of 1 hour
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.
Time frame: Through study completion, an average of 1 hour
For a given EEG channel, the connectivity inflow represents the cumulative sum of all corresponding incoming connectivity edges.
Time frame: Through study completion, an average of 1 hour
For a given EEG channel, the connectivity outflow represents the cumulative sum of all corresponding outgoing connectivity edges.
Time frame: Through study completion, an average of 1 hour
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).
Time frame: Through study completion, an average of 1 hour
A 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.
Time frame: Through study completion, an average of 1 hour
A 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.
Time frame: Through study completion, an average of 1 hour
The 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.
Time frame: 1 day
Five 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.
Time frame: 1 day
Montreal 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.
Time frame: 1 day
Beck 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.
Time frame: 1 day
Beck 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.
Time frame: 1 day
Mind 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.
Time frame: 1 day
Pittsburgh 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.
Hei-Yin Hydra Ng
Other
Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance: an Extensive Exploration of EEG Markers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.