StressNCT07591935
AI and Mindfulness Meditation for Stress Reduction in Medical Students
A study testing Mindfulness-Based Stress Reduction Course and Apollo Neuro Wearable in people with Stress, run by Saint James School of Medicine at 1 site in Anguilla.
Trial summary
The goal of this clinical trial is to learn if two stress-reduction methods can lower stress in medical students. The study compares a wearable device and a mindfulness program. The wearable device sends gentle vibrations to the body, while the mindfulness program teaches meditation and stress awareness skills. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness-Based Stress Reduction Course and Apollo Neuro Wearable
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAnguilla
- Study dates
- 15 May 2024to 6 Oct 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical Student at Saint James Medical School
- Proficient in English
Who cannot join
- Insufficient stress levels
- Already owning an Apollo Device
- Inability to provide informed consent
- Have any medical condition that precluded the use of Apollo
Trial locations and contacts
1 site in 1 country.
Anguilla1 site
Saint James School of Medicine
The Quarter
About this study
Official title: Artificial Intelligence and Mindfulness Meditation: Innovative Methods to Reduce Stress Amongst Medical School Students
The goal of this clinical trial is to learn if two stress-reduction methods can lower stress in medical students. The study compares a wearable device and a mindfulness program. The wearable device sends gentle vibrations to the body, while the mindfulness program teaches meditation and stress awareness skills.
The main questions it aims to answer are:
Read more
- Does the wearable device lower stress levels in medical students?
- Does mindfulness meditation lower stress levels in medical students?
- Is one method more effective than the other?
Researchers will compare the wearable device to the mindfulness program to see if one works better for reducing stress.
Participants are medical students from Saint James School of Medicine. Each participant will try both methods during the study. Participants will:
- Use the wearable device daily for four weeks
- Complete a four-week mindfulness meditation program
- Take a one-week break between the two methods
- Complete surveys about stress and satisfaction
- Have heart rate variability (HRV) measured to assess stress levels
This study will help researchers understand whether wearable technology or mindfulness training is more effective for managing stress in medical students. It may also show if both methods can improve how the body responds to stress over time.
Read the detailed description
This study is a randomized, unblinded, two-period crossover clinical trial designed to evaluate and compare the effects of a wearable stress-modulation device and a mindfulness-based stress reduction (MBSR) program on stress levels in medical students.
Stress is common among medical students due to academic demands and challenges with maintaining work-life balance. Chronic stress can negatively affect both mental and physical health, including cognitive performance and emotional well-being. Interventions that improve stress regulation may help support student health and academic success.
This study investigates two non-invasive approaches to stress reduction: a wearable device that delivers gentle vibratory stimulation intended to regulate the autonomic nervous system, and a structured mindfulness meditation program designed to improve stress awareness and emotional regulation.
A total of 20 medical students from Saint James School of Medicine were enrolled and randomly assigned in a 1:1 ratio to one of two sequences:
- Sequence AB: mindfulness-based stress reduction (MBSR) followed by the wearable device
- Sequence BA: wearable device followed by MBSR
Each intervention period lasted four weeks and was separated by a one-week washout period to reduce potential carryover effects.
Participants in the MBSR group completed a structured mindfulness program focused on meditation practices and stress management techniques. Participants in the wearable device group used the device regularly during daily activities.
Outcome measures included both subjective and objective assessments:
- Heart rate variability (HRV), used as a physiological marker of autonomic nervous system regulation and stress response
- Patient Satisfaction Questionnaire (PSQ), using a five-point Likert scale
- Qualitative surveys to assess participant experiences and perceived stress
The primary objective was to determine whether the wearable device is more effective than mindfulness meditation in reducing stress, as measured by HRV and self-reported outcomes.
Results showed no statistically significant difference between the two interventions in terms of HRV or patient-reported satisfaction. However, both interventions were associated with improvements in HRV over time, suggesting enhanced autonomic regulation. Mindfulness-based stress reduction demonstrated a stronger initial effect, while the wearable device showed smaller but consistent improvements. No significant carryover effects were observed between intervention periods.
These findings suggest that both interventions may support stress reduction and improved autonomic nervous system function in medical students. The wearable device offers a practical advantage, as it can be used during daily activities without requiring dedicated time for practice, unlike mindfulness training.
Future research should include larger sample sizes, consider cultural and environmental factors influencing stress, and use blinded study designs to reduce bias.
- Conditions
- Stress
- Being tested
- Mindfulness-Based Stress Reduction Course, Apollo Neuro Wearable
- Keywords
- Vagus Nerve, Apollo Neuro, Heart Rate Variability, Perceived Stress Questionnaire, Mindfulness-Based Stress Reduction, Medical Students, Stress, AI wearable device, Hypothalamus-pituitary axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction CourseBehavioural
The MBSR intervention is an evidence-based structured mindfulness program designed to reduce stress and improve psychological wellbeing. Participants engage in guided mindfulness practices including focused attention meditation, body scanning, and breathing exercises. The intervention emphasizes present-moment awareness and non-judgmental observation of thoughts and emotions. Sessions are delivered over a defined study period and are complemented by brief daily at-home mindfulness practice. The goal is to reduce perceived stress, in medical students through repeated mindfulness training and cognitive regulation strategies.
Apollo Neuro WearableDevice
The Apollo Neuro intervention involves the use of a wearable neuromodulation device designed to support stress regulation through gentle, non-invasive vibration patterns. The device delivers low-frequency tactile stimulation intended to promote parasympathetic nervous system activation and improve autonomic balance. Participants wear the device during designated periods throughout the day (e.g., study, relaxation, or sleep) according to a standardized protocol. The intervention aims to reduce physiological and perceived stress levels through continuous somatic signaling and nervous system modulation
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Participants assigned to Sequence AB receive Treatment A in Period 1 followed by Treatment B in Period 2, with a washout period between treatments. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered over the first study period. Treatment B consists of a control or alternative stress-reduction condition delivered over the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject changes in stress and wellbeing. Receives: Device: Apollo Neuro Wearable |
| Sequence BA | Active comparator | Participants assigned to Sequence BA receive Treatment B in Period 1 followed by Treatment A in Period 2, with a washout period between treatments. Treatment B consists of a control or alternative stress-reduction condition delivered during the first study period. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered during the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject differences in stress and wellbeing. Receives: Behavioral: Mindfulness-Based Stress Reduction Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Questionnaire
The primary outcome is change in perceived stress among medical students, measured using a validated self-report linear Likert scale such as the Perceived Stress Questionnaire. This measure assesses the degree to which participants perceive their life situations as stressful, including feelings of overload, unpredictability, and lack of control. PSQ scores will be compared within participants in a randomized two-period crossover design evaluating the effects of a 4-week Mindfulness-Based Stress Reduction (MBSR) program and a 4-week Apollo Neuro device intervention.
Measured: Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).
Secondary outcomes (1)
Heart Rate Variability
Heart rate variability (HRV) is a secondary physiological outcome used to assess autonomic nervous system regulation and stress response. HRV reflects the variation in time intervals between consecutive heartbeats and serves as an objective marker of parasympathetic (vagal) activity and stress resilience. In this randomized two-period, two-sequence (AB/BA) crossover study, each participant serves as their own control, allowing within-subject comparison of HRV across intervention conditions. HRV measurements are used to evaluate changes in physiological stress regulation in response to each intervention period.
Measured: During each intervention period (approximately 4 weeks per period), with comparison of HRV outcomes between Period 1 and Period 2 following completion of each phase of the crossover design (approximately 8 weeks total after enrolment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 May 2024
- Primary completion24 Sep 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint James School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zabrina Kerr, Saint James School of Medicine
- Investigators
- Mykhailo Vysochyn, MD, PhD, Principal investigator, Saint James School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591935
- Sponsor's protocol ID
- SaintJamesSoM
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to the small sample size (n=20), sensitive physiological and psychological measures, lack of data-sharing infrastructure, and no requirement for public IPD sharing.
Publications
Foxman B. Determining the Reliability and Validity and Interpretation of a Measure in the Study Populations. Molecular Tools and Infectious Disease Epidemiology. 2012:117-32. doi: 10.1016/B978-0-12-374133-2.00008-3. Epub 2011 Jan 27. PMCID: PMC7158331.
Kim SH, Lim KR, Seo JH, Ryu DR, Lee BK, Cho BR, Chun KJ. Higher heart rate variability as a predictor of atrial fibrillation in patients with hypertension. Sci Rep. 2022 Mar 8;12(1):3702. doi: 10.1038/s41598-022-07783-3.
PubMed 35260686Ross JA, Van Bockstaele EJ. The Locus Coeruleus- Norepinephrine System in Stress and Arousal: Unraveling Historical, Current, and Future Perspectives. Front Psychiatry. 2021 Jan 27;11:601519. doi: 10.3389/fpsyt.2020.601519. eCollection 2020.
PubMed 33584368Yon D, Zainzinger V, de Lange FP, Eimer M, Press C. Action biases perceptual decisions toward expected outcomes. J Exp Psychol Gen. 2021 Jun;150(6):1225-1236. doi: 10.1037/xge0000826. Epub 2020 Dec 7.
PubMed 33289575Zhang D, Shen X, Qi X. Resting heart rate and all-cause and cardiovascular mortality in the general population: a meta-analysis. CMAJ. 2016 Feb 16;188(3):E53-E63. doi: 10.1503/cmaj.150535. Epub 2015 Nov 23.
PubMed 26598376Yaribeygi H, Panahi Y, Sahraei H, Johnston TP, Sahebkar A. The impact of stress on body function: A review. EXCLI J. 2017 Jul 21;16:1057-1072. doi: 10.17179/excli2017-480. eCollection 2017.
PubMed 28900385Vogel S, Schwabe L. Learning and memory under stress: implications for the classroom. NPJ Sci Learn. 2016 Jun 29;1:16011. doi: 10.1038/npjscilearn.2016.11. eCollection 2016.
PubMed 30792896Vinik AI, Ziegler D. Diabetic cardiovascular autonomic neuropathy. Circulation. 2007 Jan 23;115(3):387-97. doi: 10.1161/CIRCULATIONAHA.106.634949. No abstract available.
PubMed 17242296Vibrating Wristband For Stress & Anxiety: How it Works | Apollo Neuro. (2024). Apollo Neuro. https://apolloneuro.com/en-intl/pages/how-to-use?srsltid=AfmBOornFhGUz9Pj3Ha3fn1v0lz0KyZjhXhgczUvFv1Ws617jQ2rx09l
Valentino RJ, Foote SL, Aston-Jones G. Corticotropin-releasing factor activates noradrenergic neurons of the locus coeruleus. Brain Res. 1983 Jul 4;270(2):363-7. doi: 10.1016/0006-8993(83)90615-7.
PubMed 6603889Office of the Surgeon General (US); Center for Mental Health Services (US); National Institute of Mental Health (US). Mental Health: Culture, Race, and Ethnicity: A Supplement to Mental Health: A Report of the Surgeon General. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2001 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK44243/
PubMed 20669516Trofin DM, Sardaru DP, Trofin D, Onu I, Tutu A, Onu A, Onita C, Galaction AI, Matei DV. Oxidative Stress in Brain Function. Antioxidants (Basel). 2025 Feb 28;14(3):297. doi: 10.3390/antiox14030297.
PubMed 40227270The science behind Apollo Vibes. (2023). Apollo Neuro. https://apolloneuro.com/en-intl/blogs/news/science-behind vibes?srsltid=AfmBOoraBiIgAO7cJxj40rmKaZRS0PquEsT-xpEgkYMx_CkHtBLtGTn6.
Tiwari R, Kumar R, Malik S, Raj T, Kumar P. Analysis of Heart Rate Variability and Implication of Different Factors on Heart Rate Variability. Curr Cardiol Rev. 2021;17(5):e160721189770. doi: 10.2174/1573403X16999201231203854.
PubMed 33390146Tindle J, Tadi P. Neuroanatomy, Parasympathetic Nervous System. 2022 Oct 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553141/
PubMed 31985934
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence and Mindfulness Meditation: Innovative Methods to Reduce Stress Amongst Medical School Students
- ClinicalTrials.gov ID
- NCT07591935
- Acronym / sponsor ID
- SaintJamesSoM
- Conditions
- Stress
- Keywords
- Vagus Nerve, Apollo Neuro, Heart Rate Variability, Perceived Stress Questionnaire, Mindfulness-Based Stress Reduction, Medical Students, Stress, AI wearable device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saint James School of MedicineUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 18 May 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.
The goal of this clinical trial is to learn if two stress-reduction methods can lower stress in medical students. The study compares a wearable device and a mindfulness program. The wearable device sends gentle vibrations to the body, while the mindfulness program teaches meditation and stress awareness skills.
The main questions it aims to answer are:
- Does the wearable device lower stress levels in medical students?
- Does mindfulness meditation lower stress levels in medical students?
- Is one method more effective than the other?
Researchers will compare the wearable device to the mindfulness program to see if one works better for reducing stress.
Participants are medical students from Saint James School of Medicine. Each participant will try both methods during the study. Participants will:
- Use the wearable device daily for four weeks
- Complete a four-week mindfulness meditation program
- Take a one-week break between the two methods
- Complete surveys about stress and satisfaction
- Have heart rate variability (HRV) measured to assess stress levels
This study will help researchers understand whether wearable technology or mindfulness training is more effective for managing stress in medical students. It may also show if both methods can improve how the body responds to stress over time.
Detailed description
This study is a randomized, unblinded, two-period crossover clinical trial designed to evaluate and compare the effects of a wearable stress-modulation device and a mindfulness-based stress reduction (MBSR) program on stress levels in medical students.
Stress is common among medical students due to academic demands and challenges with maintaining work-life balance. Chronic stress can negatively affect both mental and physical health, including cognitive performance and emotional well-being. Interventions that improve stress regulation may help support student health and academic success.
This study investigates two non-invasive approaches to stress reduction: a wearable device that delivers gentle vibratory stimulation intended to regulate the autonomic nervous system, and a structured mindfulness meditation program designed to improve stress awareness and emotional regulation.
A total of 20 medical students from Saint James School of Medicine were enrolled and randomly assigned in a 1:1 ratio to one of two sequences:
- Sequence AB: mindfulness-based stress reduction (MBSR) followed by the wearable device
- Sequence BA: wearable device followed by MBSR
Each intervention period lasted four weeks and was separated by a one-week washout period to reduce potential carryover effects.
Participants in the MBSR group completed a structured mindfulness program focused on meditation practices and stress management techniques. Participants in the wearable device group used the device regularly during daily activities.
Outcome measures included both subjective and objective assessments:
- Heart rate variability (HRV), used as a physiological marker of autonomic nervous system regulation and stress response
- Patient Satisfaction Questionnaire (PSQ), using a five-point Likert scale
- Qualitative surveys to assess participant experiences and perceived stress
The primary objective was to determine whether the wearable device is more effective than mindfulness meditation in reducing stress, as measured by HRV and self-reported outcomes.
Results showed no statistically significant difference between the two interventions in terms of HRV or patient-reported satisfaction. However, both interventions were associated with improvements in HRV over time, suggesting enhanced autonomic regulation. Mindfulness-based stress reduction demonstrated a stronger initial effect, while the wearable device showed smaller but consistent improvements. No significant carryover effects were observed between intervention periods.
These findings suggest that both interventions may support stress reduction and improved autonomic nervous system function in medical students. The wearable device offers a practical advantage, as it can be used during daily activities without requiring dedicated time for practice, unlike mindfulness training.
Future research should include larger sample sizes, consider cultural and environmental factors influencing stress, and use blinded study designs to reduce bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Device: Apollo Neuro WearableParticipants assigned to Sequence AB receive Treatment A in Period 1 followed by Treatment B in Period 2, with a washout period between treatments. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered over the first study period. Treatment B consists of a control or alternative stress-reduction condition delivered over the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject changes in stress and wellbeing. |
| Sequence BA | Active comparator | Behavioral: Mindfulness-Based Stress Reduction CourseParticipants assigned to Sequence BA receive Treatment B in Period 1 followed by Treatment A in Period 2, with a washout period between treatments. Treatment B consists of a control or alternative stress-reduction condition delivered during the first study period. Treatment A consists of an AI-supported mindfulness-based stress reduction (MBSR-style) intervention delivered during the second study period. Outcomes are assessed at baseline and at the end of each period to evaluate within-subject differences in stress and wellbeing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical Student at Saint James Medical School
- Proficient in English
Key exclusion criteria (4 listed)
- Insufficient stress levels
- Already owning an Apollo Device
- Inability to provide informed consent
- Have any medical condition that precluded the use of Apollo
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 |
|---|---|---|
| Mindfulness-Based Stress Reduction CourseThe MBSR intervention is an evidence-based structured mindfulness program designed to reduce stress and improve psychological wellbeing. Participants engage in guided mindfulness practices including focused attention meditation, body scanning, and breathing exercises. The intervention emphasizes present-moment awareness and non-judgmental observation of thoughts and emotions. Sessions are delivered over a defined study period and are complemented by brief daily at-home mindfulness practice. The goal is to reduce perceived stress, in medical students through repeated mindfulness training and cognitive regulation strategies. | Behavioural | Sequence BA |
| Apollo Neuro WearableThe Apollo Neuro intervention involves the use of a wearable neuromodulation device designed to support stress regulation through gentle, non-invasive vibration patterns. The device delivers low-frequency tactile stimulation intended to promote parasympathetic nervous system activation and improve autonomic balance. Participants wear the device during designated periods throughout the day (e.g., study, relaxation, or sleep) according to a standardized protocol. The intervention aims to reduce physiological and perceived stress levels through continuous somatic signaling and nervous system modulation | Device | Sequence AB |
Primary outcome
Perceived Stress Questionnaire
Time frame: Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).
The primary outcome is change in perceived stress among medical students, measured using a validated self-report linear Likert scale such as the Perceived Stress Questionnaire. This measure assesses the degree to which participants perceive their life situations as stressful, including feelings of overload, unpredictability, and lack of control. PSQ scores will be compared within participants in a randomized two-period crossover design evaluating the effects of a 4-week Mindfulness-Based Stress Reduction (MBSR) program and a 4-week Apollo Neuro device intervention.
1 secondary outcome
Heart Rate Variability
Time frame: During each intervention period (approximately 4 weeks per period), with comparison of HRV outcomes between Period 1 and Period 2 following completion of each phase of the crossover design (approximately 8 weeks total after enrolment).
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 18 May 2026.
- BackgroundFoxman B. Determining the Reliability and Validity and Interpretation of a Measure in the Study Populations. Molecular Tools and Infectious Disease Epidemiology. 2012:117-32. doi: 10.1016/B978-0-12-374133-2.00008-3. Epub 2011 Jan 27. PMCID: PMC7158331.
- Background: PubMed 35260686Kim SH, Lim KR, Seo JH, Ryu DR, Lee BK, Cho BR, Chun KJ. Higher heart rate variability as a predictor of atrial fibrillation in patients with hypertension. Sci Rep. 2022 Mar 8;12(1):3702. doi: 10.1038/s41598-022-07783-3.
- Background: PubMed 33584368Ross JA, Van Bockstaele EJ. The Locus Coeruleus- Norepinephrine System in Stress and Arousal: Unraveling Historical, Current, and Future Perspectives. Front Psychiatry. 2021 Jan 27;11:601519. doi: 10.3389/fpsyt.2020.601519. eCollection 2020.
- Background: PubMed 33289575Yon D, Zainzinger V, de Lange FP, Eimer M, Press C. Action biases perceptual decisions toward expected outcomes. J Exp Psychol Gen. 2021 Jun;150(6):1225-1236. doi: 10.1037/xge0000826. Epub 2020 Dec 7.
- Background: PubMed 26598376Zhang D, Shen X, Qi X. Resting heart rate and all-cause and cardiovascular mortality in the general population: a meta-analysis. CMAJ. 2016 Feb 16;188(3):E53-E63. doi: 10.1503/cmaj.150535. Epub 2015 Nov 23.
- Background: PubMed 28900385Yaribeygi H, Panahi Y, Sahraei H, Johnston TP, Sahebkar A. The impact of stress on body function: A review. EXCLI J. 2017 Jul 21;16:1057-1072. doi: 10.17179/excli2017-480. eCollection 2017.
- Background: PubMed 30792896Vogel S, Schwabe L. Learning and memory under stress: implications for the classroom. NPJ Sci Learn. 2016 Jun 29;1:16011. doi: 10.1038/npjscilearn.2016.11. eCollection 2016.
- Background: PubMed 17242296Vinik AI, Ziegler D. Diabetic cardiovascular autonomic neuropathy. Circulation. 2007 Jan 23;115(3):387-97. doi: 10.1161/CIRCULATIONAHA.106.634949. No abstract available.
- BackgroundVibrating Wristband For Stress & Anxiety: How it Works | Apollo Neuro. (2024). Apollo Neuro. https://apolloneuro.com/en-intl/pages/how-to-use?srsltid=AfmBOornFhGUz9Pj3Ha3fn1v0lz0KyZjhXhgczUvFv1Ws617jQ2rx09l
- Background: PubMed 6603889Valentino RJ, Foote SL, Aston-Jones G. Corticotropin-releasing factor activates noradrenergic neurons of the locus coeruleus. Brain Res. 1983 Jul 4;270(2):363-7. doi: 10.1016/0006-8993(83)90615-7.
- Background: PubMed 20669516Office of the Surgeon General (US); Center for Mental Health Services (US); National Institute of Mental Health (US). Mental Health: Culture, Race, and Ethnicity: A Supplement to Mental Health: A Report of the Surgeon General. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2001 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK44243/
- Background: PubMed 40227270Trofin DM, Sardaru DP, Trofin D, Onu I, Tutu A, Onu A, Onita C, Galaction AI, Matei DV. Oxidative Stress in Brain Function. Antioxidants (Basel). 2025 Feb 28;14(3):297. doi: 10.3390/antiox14030297.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to the small sample size (n=20), sensitive physiological and psychological measures, lack of data-sharing infrastructure, and no requirement for public IPD sharing.
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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.
Mykhailo Vysochyn, MD, PhD principal investigator
Saint James School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction Course and Apollo Neuro Wearable in people with Stress, run by Saint James School of Medicine at 1 site in Anguilla.
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 4 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 18 May 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 Anguilla. 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?
Perceived Stress Questionnaire (time frame: Baseline; Week 4 (end of Period 1); Week 9 (end of Period 2).). 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 NCT07591935, which also lists 60 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 18 May 2026.