Breath Training StylesNCT06656741
Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance
A study testing Resting State, Mindful Breathing and Guided Breathing in people with Breath Training Styles, run by Hei-Yin Hydra Ng at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breath Training Styles
- What is being tested?
- Resting State, Mindful Breathing and Guided Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged between 20 and 80.
- Normal vision or corrected-to-normal vision.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance: an Extensive Exploration of EEG Markers
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:
Read more
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.
Read the detailed description
- 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).
- Research Participants Age range: 20-80 years old. Total: 53 participants. Withdrawal Criteria: Participants can withdraw at any point if they feel discomfort.
- Compensation for Participation: Participants will receive a total of NT$1,000.
- 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.
- Potential Side Effects, Follow-Up Procedures, and Necessary Rehabilitation Plans
- 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.
- 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.
- 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.
- Privacy and Data Confidentiality
- All collected data and samples will be securely locked, and electronic data will be stored on password-protected systems.
- 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.
- 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.
- 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.
- 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
- Being tested
- Resting State, Mindful Breathing, Guided Breathing, Breath Counting
- Keywords
- bio-feedback, virtual reality, breath training, EEG, effective connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting StateBehavioural
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 BreathingBehavioural
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 BreathingBehavioural
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 CountingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resting State; Behavioral: Mindful Breathing; Behavioral: Guided Breathing; Behavioral: Breath Counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start11 May 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breath Training StylesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hei-Yin Hydra Ng
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor-investigator, Hei-Yin Hydra Ng, National Tsing Hua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656741
- Sponsor's protocol ID
- NCTU-REC-109-037F
- Other IDs
- MOST 110-2636-E007-018
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: National Yang Ming Chiao Tung University - Research Ethics Center for Human Subject Protection (NYCU-REC) reviewed and approved this study (Project Number: NCTU-REC-109-037F). In accordance with the regulations of NYCU-REC, only the project-related personnel, as listed in NYCU-REC (Project Number: NCTU-REC-109-037F), may access the individual participant data.
Publications
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.
PubMed 35972793Luddecke 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.
PubMed 34860290Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
PubMed 23777436Ng 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.
PubMed 39642375
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Evidence of Diverse Self-Help Breathing Trainings with Virtual Reality and Bio-Feedback Assistance: an Extensive Exploration of EEG Markers
- ClinicalTrials.gov ID
- NCT06656741
- Acronym / sponsor ID
- NCTU-REC-109-037F
- Conditions
- Breath Training Styles
- Keywords
- bio-feedback, virtual reality, breath training, EEG, effective connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hei-Yin Hydra NgUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- Research Participants Age range: 20-80 years old. Total: 53 participants. Withdrawal Criteria: Participants can withdraw at any point if they feel discomfort.
- Compensation for Participation: Participants will receive a total of NT$1,000.
- 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.
- Potential Side Effects, Follow-Up Procedures, and Necessary Rehabilitation Plans
- 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.
- 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.
- 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.
- Privacy and Data Confidentiality
- All collected data and samples will be securely locked, and electronic data will be stored on password-protected systems.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Behavioral: Resting State, Behavioral: Mindful Breathing, Behavioral: Guided Breathing, Behavioral: Breath CountingThis 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults aged between 20 and 80.
- Normal vision or corrected-to-normal vision.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting StateResting 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. | Behavioural | Single group |
| Mindful BreathingMindful 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. | Behavioural | Single group |
| Guided BreathingGuided 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). | Behavioural | Single group |
| Breath CountingBreath 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. | Behavioural | Single group |
Primary outcome
EEG effective connectivity(dDTF)
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.
EEG connectivity inflow
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.
EEG connectivity outflow
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.
EEG band power
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 35972793Lukic 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.
- Background: PubMed 34860290Luddecke 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.
- Background: PubMed 23777436Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
- Derived from this study: PubMed 39642375Ng 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.
- Individual participant dataSharing planned: No. National Yang Ming Chiao Tung University - Research Ethics Center for Human Subject Protection (NYCU-REC) reviewed and approved this study (Project Number: NCTU-REC-109-037F). In accordance with the regulations of NYCU-REC, only the project-related personnel, as listed in NYCU-REC (Project Number: NCTU-REC-109-037F), may access the individual participant data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting State, Mindful Breathing and Guided Breathing in people with Breath Training Styles, run by Hei-Yin Hydra Ng at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG effective connectivity(dDTF) (time frame: Through study completion, an average of 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656741, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.