Autonomic Nervous System FunctionNCT07911215
Effects of Brief Heart Rate Variability Biofeedback on Physiological and Emotional Responses
A study testing Psychoeducational Video Viewing and Heart Rate Variability Biofeedback in people with Autonomic Nervous System Function and Psychophysiological Regulation, run by University of Haifa at 1 site in Israel.
Trial summary
This completed randomized laboratory study investigated the immediate effects of a single 10-minute session of heart rate variability biofeedback (HRV-B) on cardiac activity, forehead physiological signals, and emotional responses in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Function, Psychophysiological Regulation
- What is being tested?
- Psychoeducational Video Viewing and Heart Rate Variability Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2026to 1 Oct 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Sufficient proficiency in Hebrew to understand the study instructions and questionnaires.
- Ability to provide written informed consent.
- Willingness to participate in a single laboratory session lasting approximately 60 minutes.
- Exclusion Criteria (as specified in the original approved protocol):
- Pregnancy.
Show all 10Show fewer
- Psychiatric or neurological diagnosis.
- History of cardiovascular disease or seizure disorders.
- Chronic medical illness.
- Use of medications affecting the nervous system or immune system.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of a Single HRV Biofeedback Session on Cortical Activity and Systemic Inflammation
This completed randomized laboratory study investigated the immediate effects of a single 10-minute session of heart rate variability biofeedback (HRV-B) on cardiac activity, forehead physiological signals, and emotional responses in adults.
Heart rate variability reflects changes in the time intervals between heartbeats. HRV biofeedback provides real-time information about heart rhythm patterns and allows individuals to adjust their breathing in response to visual feedback.
Read more
Thirty-two adult participants were randomly assigned to one of two groups. Sixteen participants completed HRV biofeedback training using the emWave Pro Plus system, while 16 participants watched educational videos about biofeedback and breathing.
Heart rate variability was measured before, during, and after the intervention. Forehead physiological signals were recorded using hemoencephalography (HEG) before, during, and after the session. Positive and negative affect were assessed using questionnaires completed before and after the intervention.
The purpose was to compare immediate physiological and emotional responses between participants receiving active HRV biofeedback and those receiving psychoeducational information without real-time physiological feedback.
The original ethics-approved research proposal also included a planned non-invasive bioimpedance assessment of systemic inflammation. This component was not implemented, and no inflammation-related measurements were collected.
Read the detailed description
Study Background and Objectives
This randomized, two-arm, single-session laboratory study was conducted at the University of Haifa, Israel, to investigate the immediate cardiac, forehead physiological, and affective responses to heart rate variability biofeedback (HRV-B).
The study examined whether a brief session of HRV biofeedback would produce different physiological and emotional responses compared with a time-matched psychoeducational control condition.
The original research proposal was entitled "Immediate Effects of a Single HRV Biofeedback Session on Cortical Activity and Systemic Inflammation."
The study received approval from the University of Haifa Ethics Committee for Research with Human Participants on December 29, 2025 (Approval No. 518/25). All participants provided written informed consent.
Participants and Study Design
The original research proposal planned the recruitment of up to 50 adult participants. Actual enrollment was 32 participants, randomly assigned to two groups using computerized random-number generation:
- HRV Biofeedback Group: 16 participants.
- Psychoeducational Control Group: 16 participants.
Each participant attended a single laboratory session lasting approximately 60 minutes.
Participants completed background and personality questionnaires and baseline assessments before the intervention, followed by physiological and psychological measurements during and after the experimental procedure.
HRV Biofeedback Intervention
Participants in the intervention group received a brief introduction to slow diaphragmatic breathing.
They then completed 10 minutes of HRV biofeedback using the emWave Pro Plus system (HeartMath), including a visual hot-air-balloon feedback game.
Participants were encouraged to regulate their breathing while observing real-time cardiac coherence feedback. Breathing adjustments were self-paced and guided by the visual feedback.
No individualized resonance-frequency determination, externally prescribed respiratory rate, or fixed inhalation-to-exhalation ratio was implemented.
Psychoeducational Control Condition
Participants assigned to the control group watched four consecutive educational videos lasting approximately 10 minutes in total.
The videos introduced general biofeedback principles, heart rate variability biofeedback, diaphragmatic breathing, and variations in breathing patterns.
Control participants did not receive real-time physiological feedback and were not instructed to perform guided biofeedback training during the videos.
Cardiac Physiological Measurements
Heart rate variability measurements were obtained using the emWave Pro Plus system with an earlobe photoplethysmographic sensor.
Measurements were collected during three periods:
- PRE: approximately 5 minutes before the intervention.
- DURING: 10 minutes during the intervention or control condition.
- POST: approximately 5 minutes after the intervention.
Recorded variables included heart rate, SDNN, RMSSD, total spectral power, very-low-frequency power, low-frequency power, high-frequency power, LF/HF ratio, and device-derived cardiac coherence.
Forehead Hemoencephalography Measurements
Forehead physiological signals were assessed using a BioTekna hemoencephalography (HEG) sensor positioned at Fpz.
Four approximately five-minute measurement periods were obtained:
- PRE: before the intervention.
- Block 1: first five minutes of the intervention.
- Block 2: second five minutes of the intervention.
- POST: after the intervention.
The exported variables included device-derived rCBO2 measures, within-record signal slope, and the proprietary CFB index.
These indices represent device-derived forehead physiological signals and were not independently validated as direct measurements of neuronal activation or absolute cerebral blood flow.
Psychological Measurements
Positive and negative affect were assessed immediately before and after the experimental session using the 10-item short version of the Positive and Negative Affect Schedule (PANAS).
Baseline personality characteristics were assessed using the Ten-Item Personality Inventory (TIPI).
Originally Planned Inflammation Assessment
The original ethics-approved research proposal included a non-invasive bioimpedance-based assessment of systemic inflammation using the BioTekna TomEEX system.
This planned measurement component was omitted from the implemented study. No bioimpedance-based inflammation assessments were performed, and no inflammation-related measurements or outcomes were collected or analyzed.
The completed study therefore included cardiac, forehead HEG, and psychological measurements, without an inflammatory measurement component.
Statistical Analysis and Registration
The original research proposal described a mixed-design analysis focusing on Group-by-Time interactions, with additional analyses of associations between physiological and psychological variables and possible personality-related differences in intervention responses.
The completed study used repeated-measures analyses to examine group-specific trajectories across the measurement periods. Additional exploratory analyses and post hoc sensitivity analyses were conducted.
The present ClinicalTrials.gov record was created retrospectively, after completion of participant enrollment and data collection. No prospective public trial registration was completed before enrollment.
- Being tested
- Psychoeducational Video Viewing, Heart Rate Variability Biofeedback
- Keywords
- Heart Rate Variability Biofeedback, Heart Rate Variability, Cardiac Coherence, Hemoencephalography, Diaphragmatic Breathing, Positive Affect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Video ViewingBehavioural
A single 10-minute session consisting of four prerecorded psychoeducational videos about biofeedback, heart rate variability, and breathing. Participants watched the videos without receiving real-time cardiac feedback or guided biofeedback training.
Heart Rate Variability BiofeedbackBehavioural
A single 10-minute session of self-paced, visual-feedback-guided heart rate variability biofeedback using the emWave Pro Plus system. Participants received diaphragmatic breathing instructions and practiced adjusting their breathing in response to real-time cardiac coherence feedback displayed through a balloon game.
| Study group | Role | What they receive |
|---|---|---|
| HRV Biofeedback | Experimental | Sixteen participants received a single 10-minute session of heart rate variability biofeedback using the emWave Pro Plus system (HeartMath). Following brief instruction in diaphragmatic breathing, participants practiced self-paced breathing while receiving real-time visual cardiac coherence feedback through a hot-air-balloon game. No individualized resonance-frequency assessment or externally prescribed breathing rate was used. Receives: Behavioral: Heart Rate Variability Biofeedback |
| Psychoeducational Video Control | Active comparator | Sixteen participants watched four consecutive psychoeducational videos lasting approximately 10 minutes in total. The videos addressed biofeedback principles, heart rate variability biofeedback, diaphragmatic breathing, and variations in breathing patterns. Participants received no real-time physiological feedback and were not instructed to perform guided biofeedback training during video viewing. Receives: Behavioral: Psychoeducational Video Viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Forehead Hemoencephalography (HEG) rCBO2 Signal
Change in the mean device-derived rCBO2 signal recorded using a BioTekna HEG sensor at Fpz. Each recording lasted approximately five minutes. The index is not a calibrated measure of neuronal activity or absolute cerebral oxygenation.
Measured: Baseline (5 minutes), intervention Block 1 (first 5 minutes), intervention Block 2 (second 5 minutes), and immediately post-intervention (5 minutes), within one laboratory visit.
Change in TomEEX-Derived Extracellular Bioimpedance Indices (Not Assessed)
The original ethics-approved study protocol included assessment of extracellular bioimpedance indices using the BioTekna TomEEX system, including ECR, DECW+, BEC, and DECW, as proposed indicators related to systemic inflammation. This component was omitted from the implemented study. No TomEEX assessments were performed, and no inflammation-related outcome data were collected or analyzed.
Measured: Originally planned at baseline and immediately after the 10-minute intervention, during one laboratory visit. Measurements were not performed.
Secondary outcomes (4)
Change in Heart Rate Variability (SDNN)
Standard deviation of normal-to-normal heart period intervals (SDNN), expressed in milliseconds, derived from emWave Pro Plus earlobe photoplethysmography recordings. Values were assessed across baseline, intervention, and immediate post-intervention periods.
Measured: Baseline (5 minutes), during the 10-minute intervention, and immediately afterward (5 minutes), within one laboratory visit.
Change in Device-Derived Cardiac Coherence
Normalized cardiac coherence percentage exported by the emWave Pro Plus system. The measure describes the device-derived organization of heart rhythm oscillations during the recording and should not be interpreted as a direct measurement of vagal tone.
Measured: Baseline (5 minutes), during the 10-minute intervention, and immediately afterward (5 minutes), within one laboratory visit.
Change in Positive Affect Score
Positive Affect score from the 10-item short form of the Positive and Negative Affect Schedule (PANAS). Five items are summed to yield a score ranging from 5 to 25, with higher scores indicating greater positive affect.
Measured: Immediately before and immediately after the 10-minute intervention, within one laboratory visit.
Change in Negative Affect Score
Negative Affect score from the 10-item short form of the Positive and Negative Affect Schedule (PANAS). Five items are summed to yield a score ranging from 5 to 25, with higher scores indicating greater negative affect.
Measured: Immediately before and immediately after the 10-minute intervention, within one laboratory visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jul 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System FunctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: a single 10-minute session of heart rate variability biofeedback with real-time visual feedback, or a time-matched psychoeducational video control condition. Each participant completed one laboratory session. Cardiac and forehead physiological measurements were obtained before, during, and after the intervention, while affect was assessed before and after the session. No crossover between groups occurred.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram Gidron, Ph.D., Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911215
- Sponsor's protocol ID
- UHAIFA-HRVB-LAB-2026-01
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant-level data with researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a Single HRV Biofeedback Session on Cortical Activity and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT07911215
- Acronym / sponsor ID
- UHAIFA-HRVB-LAB-2026-01
- Keywords
- Heart Rate Variability Biofeedback, Heart Rate Variability, Cardiac Coherence, Hemoencephalography, Diaphragmatic Breathing, Positive Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 2 Nov 2026 (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.
This completed randomized laboratory study investigated the immediate effects of a single 10-minute session of heart rate variability biofeedback (HRV-B) on cardiac activity, forehead physiological signals, and emotional responses in adults.
Heart rate variability reflects changes in the time intervals between heartbeats. HRV biofeedback provides real-time information about heart rhythm patterns and allows individuals to adjust their breathing in response to visual feedback.
Thirty-two adult participants were randomly assigned to one of two groups. Sixteen participants completed HRV biofeedback training using the emWave Pro Plus system, while 16 participants watched educational videos about biofeedback and breathing.
Heart rate variability was measured before, during, and after the intervention. Forehead physiological signals were recorded using hemoencephalography (HEG) before, during, and after the session. Positive and negative affect were assessed using questionnaires completed before and after the intervention.
The purpose was to compare immediate physiological and emotional responses between participants receiving active HRV biofeedback and those receiving psychoeducational information without real-time physiological feedback.
The original ethics-approved research proposal also included a planned non-invasive bioimpedance assessment of systemic inflammation. This component was not implemented, and no inflammation-related measurements were collected.
Detailed description
Study Background and Objectives
This randomized, two-arm, single-session laboratory study was conducted at the University of Haifa, Israel, to investigate the immediate cardiac, forehead physiological, and affective responses to heart rate variability biofeedback (HRV-B).
The study examined whether a brief session of HRV biofeedback would produce different physiological and emotional responses compared with a time-matched psychoeducational control condition.
The original research proposal was entitled "Immediate Effects of a Single HRV Biofeedback Session on Cortical Activity and Systemic Inflammation."
The study received approval from the University of Haifa Ethics Committee for Research with Human Participants on December 29, 2025 (Approval No. 518/25). All participants provided written informed consent.
Participants and Study Design
The original research proposal planned the recruitment of up to 50 adult participants. Actual enrollment was 32 participants, randomly assigned to two groups using computerized random-number generation:
- HRV Biofeedback Group: 16 participants.
- Psychoeducational Control Group: 16 participants.
Each participant attended a single laboratory session lasting approximately 60 minutes.
Participants completed background and personality questionnaires and baseline assessments before the intervention, followed by physiological and psychological measurements during and after the experimental procedure.
HRV Biofeedback Intervention
Participants in the intervention group received a brief introduction to slow diaphragmatic breathing.
They then completed 10 minutes of HRV biofeedback using the emWave Pro Plus system (HeartMath), including a visual hot-air-balloon feedback game.
Participants were encouraged to regulate their breathing while observing real-time cardiac coherence feedback. Breathing adjustments were self-paced and guided by the visual feedback.
No individualized resonance-frequency determination, externally prescribed respiratory rate, or fixed inhalation-to-exhalation ratio was implemented.
Psychoeducational Control Condition
Participants assigned to the control group watched four consecutive educational videos lasting approximately 10 minutes in total.
The videos introduced general biofeedback principles, heart rate variability biofeedback, diaphragmatic breathing, and variations in breathing patterns.
Control participants did not receive real-time physiological feedback and were not instructed to perform guided biofeedback training during the videos.
Cardiac Physiological Measurements
Heart rate variability measurements were obtained using the emWave Pro Plus system with an earlobe photoplethysmographic sensor.
Measurements were collected during three periods:
- PRE: approximately 5 minutes before the intervention.
- DURING: 10 minutes during the intervention or control condition.
- POST: approximately 5 minutes after the intervention.
Recorded variables included heart rate, SDNN, RMSSD, total spectral power, very-low-frequency power, low-frequency power, high-frequency power, LF/HF ratio, and device-derived cardiac coherence.
Forehead Hemoencephalography Measurements
Forehead physiological signals were assessed using a BioTekna hemoencephalography (HEG) sensor positioned at Fpz.
Four approximately five-minute measurement periods were obtained:
- PRE: before the intervention.
- Block 1: first five minutes of the intervention.
- Block 2: second five minutes of the intervention.
- POST: after the intervention.
The exported variables included device-derived rCBO2 measures, within-record signal slope, and the proprietary CFB index.
These indices represent device-derived forehead physiological signals and were not independently validated as direct measurements of neuronal activation or absolute cerebral blood flow.
Psychological Measurements
Positive and negative affect were assessed immediately before and after the experimental session using the 10-item short version of the Positive and Negative Affect Schedule (PANAS).
Baseline personality characteristics were assessed using the Ten-Item Personality Inventory (TIPI).
Originally Planned Inflammation Assessment
The original ethics-approved research proposal included a non-invasive bioimpedance-based assessment of systemic inflammation using the BioTekna TomEEX system.
This planned measurement component was omitted from the implemented study. No bioimpedance-based inflammation assessments were performed, and no inflammation-related measurements or outcomes were collected or analyzed.
The completed study therefore included cardiac, forehead HEG, and psychological measurements, without an inflammatory measurement component.
Statistical Analysis and Registration
The original research proposal described a mixed-design analysis focusing on Group-by-Time interactions, with additional analyses of associations between physiological and psychological variables and possible personality-related differences in intervention responses.
The completed study used repeated-measures analyses to examine group-specific trajectories across the measurement periods. Additional exploratory analyses and post hoc sensitivity analyses were conducted.
The present ClinicalTrials.gov record was created retrospectively, after completion of participant enrollment and data collection. No prospective public trial registration was completed before enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: a single 10-minute session of heart rate variability biofeedback with real-time visual feedback, or a time-matched psychoeducational video control condition. Each participant completed one laboratory session. Cardiac and forehead physiological measurements were obtained before, during, and after the intervention, while affect was assessed before and after the session. No crossover between groups occurred.
| Arm | Type | Receives |
|---|---|---|
| HRV Biofeedback | Experimental | Behavioral: Heart Rate Variability BiofeedbackSixteen participants received a single 10-minute session of heart rate variability biofeedback using the emWave Pro Plus system (HeartMath). Following brief instruction in diaphragmatic breathing, participants practiced self-paced breathing while receiving real-time visual cardiac coherence feedback through a hot-air-balloon game. No individualized resonance-frequency assessment or externally prescribed breathing rate was used. |
| Psychoeducational Video Control | Active comparator | Behavioral: Psychoeducational Video ViewingSixteen participants watched four consecutive psychoeducational videos lasting approximately 10 minutes in total. The videos addressed biofeedback principles, heart rate variability biofeedback, diaphragmatic breathing, and variations in breathing patterns. Participants received no real-time physiological feedback and were not instructed to perform guided biofeedback training during video viewing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 18-65 years.
- Sufficient proficiency in Hebrew to understand the study instructions and questionnaires.
- Ability to provide written informed consent.
- Willingness to participate in a single laboratory session lasting approximately 60 minutes.
- Pregnancy.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Psychoeducational Video ViewingA single 10-minute session consisting of four prerecorded psychoeducational videos about biofeedback, heart rate variability, and breathing. Participants watched the videos without receiving real-time cardiac feedback or guided biofeedback training. | Behavioural | Psychoeducational Video Control |
| Heart Rate Variability BiofeedbackA single 10-minute session of self-paced, visual-feedback-guided heart rate variability biofeedback using the emWave Pro Plus system. Participants received diaphragmatic breathing instructions and practiced adjusting their breathing in response to real-time cardiac coherence feedback displayed through a balloon game. | Behavioural | HRV Biofeedback |
Primary outcome
Change in Mean Forehead Hemoencephalography (HEG) rCBO2 Signal
Time frame: Baseline (5 minutes), intervention Block 1 (first 5 minutes), intervention Block 2 (second 5 minutes), and immediately post-intervention (5 minutes), within one laboratory visit.
Change in the mean device-derived rCBO2 signal recorded using a BioTekna HEG sensor at Fpz. Each recording lasted approximately five minutes. The index is not a calibrated measure of neuronal activity or absolute cerebral oxygenation.
Change in TomEEX-Derived Extracellular Bioimpedance Indices (Not Assessed)
Time frame: Originally planned at baseline and immediately after the 10-minute intervention, during one laboratory visit. Measurements were not performed.
The original ethics-approved study protocol included assessment of extracellular bioimpedance indices using the BioTekna TomEEX system, including ECR, DECW+, BEC, and DECW, as proposed indicators related to systemic inflammation. This component was omitted from the implemented study. No TomEEX assessments were performed, and no inflammation-related outcome data were collected or analyzed.
4 secondary outcomes
Change in Heart Rate Variability (SDNN)
Time frame: Baseline (5 minutes), during the 10-minute intervention, and immediately afterward (5 minutes), within one laboratory visit.
Change in Device-Derived Cardiac Coherence
Time frame: Baseline (5 minutes), during the 10-minute intervention, and immediately afterward (5 minutes), within one laboratory visit.
Change in Positive Affect Score
Time frame: Immediately before and immediately after the 10-minute intervention, within one laboratory visit.
Change in Negative Affect Score
Time frame: Immediately before and immediately after the 10-minute intervention, within one laboratory visit.
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 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant-level data with researchers outside the study team.
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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.
Yoram Gidron, Ph.D. principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Video Viewing and Heart Rate Variability Biofeedback in people with Autonomic Nervous System Function and Psychophysiological Regulation, run by University of Haifa at 1 site in Israel.
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 10 inclusion and 1 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 4 Nov 2026. 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 Israel. 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?
Change in Mean Forehead Hemoencephalography (HEG) rCBO2 Signal (time frame: Baseline (5 minutes), intervention Block 1 (first 5 minutes), intervention Block 2 (second 5 minutes), and immediately post-intervention (5 minutes), within one laboratory visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.