Stress (Psychology)NCT07916818
High-Tech, High-Touch
A study testing Wearable ring with continuous biometric monitoring, AI health coaching application and Osteopathic manipulative treatment (OMT) in people with Stress (Psychology) and Resilience, Psychological, run by Touro University, California at 1 site in United States.
Trial summary
Medical students often experience high levels of stress, anxiety, and poor sleep, especially during their first year and around exams. This study looked at whether adding hands-on osteopathic manipulative treatment (OMT) to a wellness program built around a wearable ring and an artificial intelligence (AI) health… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress (Psychology), Resilience, Psychological, Anxiety
- What is being tested?
- Wearable ring with continuous biometric monitoring, AI health coaching application and Osteopathic manipulative treatment (OMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2024to 2 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled as a first-year (OMS-I) student at the participating college of osteopathic medicine
- Willing to be randomized to any of the three study arms, including an arm not receiving osteopathic manipulative treatment
- Willing to forgo osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed osteopathic manipulative medicine physician, or a European-trained osteopath for the 23-week study duration
- Willing to wear the study wearable ring daily beginning before the onset of the study period
- Willing to use the lifestyle-tracking platform daily beginning before the onset of the study period, in the event of assignment to an arm requiring it
- Willing to use the AI health coaching application daily beginning before the onset of the study period, in the event of assignment to an arm requiring it
Who cannot join
- Does not meet all inclusion criteria
- Pre-existing severe psychiatric condition, by participant self-report on the pre-study screening questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Touro University California College of Osteopathic Medicine
Vallejo, California, 94592
About this study
Official title: High-Tech, High-Touch: A Pilot Study on the Impact of AI Health Coaching, Wearables, and Osteopathic Manipulative Treatment on Medical Student Health and Resilience
Medical students often experience high levels of stress, anxiety, and poor sleep, especially during their first year and around exams. This study looked at whether adding hands-on osteopathic manipulative treatment (OMT) to a wellness program built around a wearable ring and an artificial intelligence (AI) health coaching app could help first-year medical students.
Forty-three first-year osteopathic medical students at one college took part. Each student was randomly assigned, by chance rather than by choice, to one of three groups for 23 weeks: a wearable ring alone; a wearable ring plus an AI health coaching app; or a wearable ring, the AI health coaching app, and seven OMT sessions given about every three weeks by osteopathic physicians.
Read more
All students wore the ring daily. The ring recorded information such as sleep, heart rate, and heart rate variability, which is a measure of how the nervous system responds to stress. Students also completed questionnaires about resilience and about symptoms of depression, anxiety, and stress at three points: before the semester, in the middle, and at the end. Students answered additional surveys about their experience two months and seven months after the study ended.
This was a small pilot study. Its main purpose was to find out whether a program like this can be carried out successfully and to gather the information needed to plan a larger study, rather than to determine whether OMT works. No harmful effects were reported.
Read the detailed description
This single-site, parallel-group, three-arm randomized pilot was conducted at one college of osteopathic medicine between December 2024 and May 2025, spanning a full academic semester plus pre- and post-semester baseline periods. It was designed as a feasibility and parameter-estimation study in accordance with published guidance on pilot trials, and is reported using the CONSORT extension for pilot and feasibility trials.
Randomization and participant de-identification were carried out by an independent study coordinator external to the investigative team. The research team remained blinded to group allocation for outcome assessment and analysis, with one unavoidable exception: participants receiving OMT could not be blinded to the physicians treating them.
OMT was delivered from a written protocol by three physicians board-certified in Osteopathic Neuromusculoskeletal Medicine. Sessions lasted no longer than 30 minutes and followed a fixed sequence. Each began with a TART screening examination (assessing Tissue texture change, Asymmetry, Restriction of motion, and Tenderness) with passive range-of-motion assessment of the diaphragms, spine, ribs, and extremities, together with a cranial vault hold assessment. Every participant then received the same six-technique core sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, the thoraco-abdominal diaphragm, and the pelvis. Physicians then addressed the most significant remaining somatic dysfunction using techniques from a specified set. Sessions ran from early January to early May on a three-week schedule with five days of permitted flexibility.
Wearable data were collected continuously by a third-generation ring device worn daily, with daily values exported from the device platform at study end. Survey instruments were administered electronically at three timepoints during the study and twice after its conclusion.
To limit contamination, participants in the two non-OMT arms agreed not to seek OMT from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration. Because all participants were enrolled in the required Osteopathic Principles and Practice curriculum, receipt of OMT from classmates during coursework was permitted and was not restricted or logged.
Analyses compared arms on post-study values adjusted for baseline. Because all arms shared an identical academic calendar, wearable data were additionally examined as within-participant trajectories across the semester. A whole-cohort analysis anchored to the institutional examination calendar was conducted to assess whether continuous biometrics track the academic stress cycle independently of study arm. Analyses of within-semester trajectories and of examination-anchored physiology were developed after data collection and are exploratory. Consistent with the pilot design, no correction for multiple comparisons was applied and no result is interpreted as confirmatory.
This record was created retrospectively. The trial was not registered before participant enrollment began.
- Conditions
- Stress (Psychology), Resilience, Psychological, Anxiety, Depressive Symptoms, Well-being, Sleep Quality
- Being tested
- Wearable ring with continuous biometric monitoring, AI health coaching application, Osteopathic manipulative treatment (OMT)
- Keywords
- osteopathic manipulative treatment, osteopathic manipulative medicine, OMT, OMM, medical students, medical education, wearable device, heart rate variability, digital health, student wellbeing, HRV
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable ring with continuous biometric monitoringDevice
Also called Oura Ring (generation 3)
A commercially available ring-worn wearable device providing continuous, passive physiological monitoring. Participants wore the device daily for the 23-week study period and had access to their own data through the accompanying mobile application. Daily metrics collected included nightly heart rate variability (rMSSD), sleep score, readiness score, lowest nightly heart rate, a resting heart rate contributor score, and a daytime stress score. No feedback or coaching beyond the device's standard consumer application was provided as part of this intervention.
AI health coaching applicationBehavioural
Also called Ziva Health AI health coach
A smartphone-based artificial intelligence health coaching application that delivered daily reflection prompts, guided breathing exercises, and individualized behavioral suggestions informed by wearable ring data. Daily engagement was encouraged but was neither incentivized nor enforced, and adherence was not a condition of participation. A major application update was released approximately midway through the study following reported usability problems.
Osteopathic manipulative treatment (OMT)Other
Also called Osteopathic manipulative medicine (OMM)
Seven protocoled sessions of osteopathic manipulative treatment delivered by physicians board-certified in Osteopathic Neuromusculoskeletal Medicine, each lasting no longer than 30 minutes, from early January to early May on an approximately three-week schedule with five days of permitted flexibility. Each session began with a TART screening examination (tissue texture change, asymmetry, restriction of motion, tenderness) with passive range-of-motion assessment of the diaphragms, spine, ribs, and extremities, plus cranial vault hold assessment. Every participant then received the same six-technique core sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, thoraco-abdominal diaphragm, and pelvis. Physicians then treated the most significant remaining somatic dysfunction using techniques from a specified set.
| Study group | Role | What they receive |
|---|---|---|
| Wearable ring only (control) | Active comparator | Participants received a third-generation wearable ring with a one-year membership and were asked to wear it continuously for the 23-week study period. Daily biometrics were collected passively, including nightly heart rate variability, sleep score, readiness score, lowest heart rate, a resting heart rate contributor score, and a daytime stress score. Participants had access to their own data through the device application. No AI health coaching application and no osteopathic manipulative treatment were provided. Participants in this arm agreed not to seek osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration; receipt of OMT from classmates during required coursework was permitted. Receives: Device: Wearable ring with continuous biometric monitoring |
| Wearable ring plus AI health coaching application | Active comparator | Participants received the wearable ring as in Arm 1, plus access to an AI health coaching application that delivered daily reflection prompts, guided breathing exercises, and behavioral suggestions informed by ring data. Daily use of the application was encouraged but not incentivized or enforced. A major application update was released mid-study following usability problems. No osteopathic manipulative treatment was provided. Participants in this arm agreed not to seek osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration; receipt of OMT from classmates during required coursework was permitted. Receives: Device: Wearable ring with continuous biometric monitoring; Behavioral: AI health coaching application |
| Wearable ring plus AI health coaching application plus OMT | Experimental | Participants received the wearable ring and AI health coaching application as in Arm 2, plus seven sessions of osteopathic manipulative treatment delivered by physicians board-certified in Osteopathic Neuromusculoskeletal Medicine. Sessions ran from early January to early May on an approximately three-week schedule with five days of permitted flexibility, and lasted no longer than 30 minutes each. Each session followed a written protocol beginning with TART screening and cranial assessment, then a fixed six-technique sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, thoraco-abdominal diaphragm, and pelvis. Physicians then treated the most significant remaining somatic dysfunction from a specified technique set. Receives: Device: Wearable ring with continuous biometric monitoring; Behavioral: AI health coaching application; Other: Osteopathic manipulative treatment (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resilience, measured by the Hardiness Resilience Gauge (HRG) Total Hardiness T-score
Standardized T-score derived from the Hardiness Resilience Gauge, reported in a standard score metric with a population mean of 100 and standard deviation of 15. Higher scores indicate greater psychological hardiness; the instrument's average range is 90 to 110. Total Hardiness is reported here; the Challenge, Control, and Commitment subscales are reported as secondary outcome measures.
Measured: Baseline, Month 3, and Month 6 (end of study)
Change in mood symptoms, measured by the Depression Anxiety Stress Scales-21 (DASS-21)
Three subscale scores (Depression, Anxiety, Stress). Each subscale is the sum of 7 items rated 0 to 3, multiplied by 2, giving a range of 0 to 42 per subscale. Higher scores indicate greater symptom severity.
Measured: Baseline, Month 3, and Month 6 (end of study)
Secondary outcomes (7)
Change in nightly heart rate variability
Mean overnight root mean square of successive differences (rMSSD), in milliseconds, recorded by the wearable ring. Higher values indicate greater parasympathetic activity.
Measured: Daily from baseline through month 6
Change in device-derived daytime stress score
Proprietary composite index of daytime physiological stress generated by the wearable device, reported daily. Higher values indicate greater stress. The metric begins reporting only after approximately two weeks of device wear.
Measured: Daily from baseline through month 6
Change in sleep score
Device-derived nightly composite sleep score ranging from 0 to 100. Higher values indicate better sleep.
Measured: Daily from baseline through month 6
Change in readiness score
Device-derived daily composite readiness score ranging from 0 to 100. Higher values indicate greater physiological readiness.
Measured: Daily from baseline through month 6
Change in lowest nightly heart rate
Minimum heart rate recorded overnight by the wearable device, in beats per minute. Higher values indicate greater physiological arousal.
Measured: Daily from baseline through month 6
Change in resting heart rate contributor score
Device-derived contributor score ranging from 0 to 100, in which higher values indicate a lower and more favorable resting heart rate. This field is a score rather than a rate in beats per minute, and is inversely scaled relative to heart rate.
Measured: Daily from baseline through month 6
Participant-reported tool use and perceived effectiveness after study completion
Structured survey assessing continued use of each study tool (wearable ring, AI health coaching application), perceived effectiveness on ordinal rating scales, receipt of osteopathic manipulative treatment after study completion, and free-text description of participant experience.
Measured: 2 months and 7 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start17 Nov 2024
- Primary completion16 May 2025
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress (Psychology)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel design with an additive (stepped) structure rather than a factorial one. All participants received a wearable ring. The second arm added an AI health coaching application, and the third arm added both the coaching application and osteopathic manipulative treatment. Because no arm received OMT without the coaching application, the independent contribution of each component cannot be isolated; the design compares cumulative combinations. Participants were randomized once and remained in their assigned arm for the full 23 weeks, with no crossover.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Touro University, California
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Foundation
- Responsible party
- Principal investigator, Nicole Pena, Touro University, California
- Investigators
- Nicole J Pena, DO, Principal investigator, Touro University California College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916818
- Sponsor's protocol ID
- M-1924
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 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: Individual participant data will not be made available to external researchers because informed consent for data sharing was not obtained from study participants.
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
- High-Tech, High-Touch: A Pilot Study on the Impact of AI Health Coaching, Wearables, and Osteopathic Manipulative Treatment on Medical Student Health and Resilience
- ClinicalTrials.gov ID
- NCT07916818
- Acronym / sponsor ID
- M-1924
- Conditions
- Stress (Psychology), Resilience, Psychological, Anxiety, Depressive Symptoms, Well-being, Sleep Quality
- Keywords
- osteopathic manipulative treatment, osteopathic manipulative medicine, OMT, OMM, medical students, medical education, wearable device, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Touro University, CaliforniaUniversity, hospital or other
- Collaborators
- American Osteopathic Foundation
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 4 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.
Medical students often experience high levels of stress, anxiety, and poor sleep, especially during their first year and around exams. This study looked at whether adding hands-on osteopathic manipulative treatment (OMT) to a wellness program built around a wearable ring and an artificial intelligence (AI) health coaching app could help first-year medical students.
Forty-three first-year osteopathic medical students at one college took part. Each student was randomly assigned, by chance rather than by choice, to one of three groups for 23 weeks: a wearable ring alone; a wearable ring plus an AI health coaching app; or a wearable ring, the AI health coaching app, and seven OMT sessions given about every three weeks by osteopathic physicians.
All students wore the ring daily. The ring recorded information such as sleep, heart rate, and heart rate variability, which is a measure of how the nervous system responds to stress. Students also completed questionnaires about resilience and about symptoms of depression, anxiety, and stress at three points: before the semester, in the middle, and at the end. Students answered additional surveys about their experience two months and seven months after the study ended.
This was a small pilot study. Its main purpose was to find out whether a program like this can be carried out successfully and to gather the information needed to plan a larger study, rather than to determine whether OMT works. No harmful effects were reported.
Detailed description
This single-site, parallel-group, three-arm randomized pilot was conducted at one college of osteopathic medicine between December 2024 and May 2025, spanning a full academic semester plus pre- and post-semester baseline periods. It was designed as a feasibility and parameter-estimation study in accordance with published guidance on pilot trials, and is reported using the CONSORT extension for pilot and feasibility trials.
Randomization and participant de-identification were carried out by an independent study coordinator external to the investigative team. The research team remained blinded to group allocation for outcome assessment and analysis, with one unavoidable exception: participants receiving OMT could not be blinded to the physicians treating them.
OMT was delivered from a written protocol by three physicians board-certified in Osteopathic Neuromusculoskeletal Medicine. Sessions lasted no longer than 30 minutes and followed a fixed sequence. Each began with a TART screening examination (assessing Tissue texture change, Asymmetry, Restriction of motion, and Tenderness) with passive range-of-motion assessment of the diaphragms, spine, ribs, and extremities, together with a cranial vault hold assessment. Every participant then received the same six-technique core sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, the thoraco-abdominal diaphragm, and the pelvis. Physicians then addressed the most significant remaining somatic dysfunction using techniques from a specified set. Sessions ran from early January to early May on a three-week schedule with five days of permitted flexibility.
Wearable data were collected continuously by a third-generation ring device worn daily, with daily values exported from the device platform at study end. Survey instruments were administered electronically at three timepoints during the study and twice after its conclusion.
To limit contamination, participants in the two non-OMT arms agreed not to seek OMT from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration. Because all participants were enrolled in the required Osteopathic Principles and Practice curriculum, receipt of OMT from classmates during coursework was permitted and was not restricted or logged.
Analyses compared arms on post-study values adjusted for baseline. Because all arms shared an identical academic calendar, wearable data were additionally examined as within-participant trajectories across the semester. A whole-cohort analysis anchored to the institutional examination calendar was conducted to assess whether continuous biometrics track the academic stress cycle independently of study arm. Analyses of within-semester trajectories and of examination-anchored physiology were developed after data collection and are exploratory. Consistent with the pilot design, no correction for multiple comparisons was applied and no result is interpreted as confirmatory.
This record was created retrospectively. The trial was not registered before participant enrollment began.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel design with an additive (stepped) structure rather than a factorial one. All participants received a wearable ring. The second arm added an AI health coaching application, and the third arm added both the coaching application and osteopathic manipulative treatment. Because no arm received OMT without the coaching application, the independent contribution of each component cannot be isolated; the design compares cumulative combinations. Participants were randomized once and remained in their assigned arm for the full 23 weeks, with no crossover.
| Arm | Type | Receives |
|---|---|---|
| Wearable ring only (control) | Active comparator | Device: Wearable ring with continuous biometric monitoringParticipants received a third-generation wearable ring with a one-year membership and were asked to wear it continuously for the 23-week study period. Daily biometrics were collected passively, including nightly heart rate variability, sleep score, readiness score, lowest heart rate, a resting heart rate contributor score, and a daytime stress score. Participants had access to their own data through the device application. No AI health coaching application and no osteopathic manipulative treatment were provided. Participants in this arm agreed not to seek osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration; receipt of OMT from classmates during required coursework was permitted. |
| Wearable ring plus AI health coaching application | Active comparator | Device: Wearable ring with continuous biometric monitoring, Behavioral: AI health coaching applicationParticipants received the wearable ring as in Arm 1, plus access to an AI health coaching application that delivered daily reflection prompts, guided breathing exercises, and behavioral suggestions informed by ring data. Daily use of the application was encouraged but not incentivized or enforced. A major application update was released mid-study following usability problems. No osteopathic manipulative treatment was provided. Participants in this arm agreed not to seek osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed OMM physician, or a European-trained osteopath for the study duration; receipt of OMT from classmates during required coursework was permitted. |
| Wearable ring plus AI health coaching application plus OMT | Experimental | Device: Wearable ring with continuous biometric monitoring, Behavioral: AI health coaching application, Other: Osteopathic manipulative treatment (OMT)Participants received the wearable ring and AI health coaching application as in Arm 2, plus seven sessions of osteopathic manipulative treatment delivered by physicians board-certified in Osteopathic Neuromusculoskeletal Medicine. Sessions ran from early January to early May on an approximately three-week schedule with five days of permitted flexibility, and lasted no longer than 30 minutes each. Each session followed a written protocol beginning with TART screening and cranial assessment, then a fixed six-technique sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, thoraco-abdominal diaphragm, and pelvis. Physicians then treated the most significant remaining somatic dysfunction from a specified technique set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently enrolled as a first-year (OMS-I) student at the participating college of osteopathic medicine
- Willing to be randomized to any of the three study arms, including an arm not receiving osteopathic manipulative treatment
- Willing to forgo osteopathic manipulative treatment from the institutional osteopathic manipulative medicine clinic, a licensed osteopathic manipulative medicine physician, or a European-trained osteopath for the 23-week study duration
- Willing to wear the study wearable ring daily beginning before the onset of the study period
- Willing to use the lifestyle-tracking platform daily beginning before the onset of the study period, in the event of assignment to an arm requiring it
Key exclusion criteria (2 listed)
- Does not meet all inclusion criteria
- Pre-existing severe psychiatric condition, by participant self-report on the pre-study screening questionnaire
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 |
|---|---|---|
| Wearable ring with continuous biometric monitoringAlso: Oura Ring (generation 3)A commercially available ring-worn wearable device providing continuous, passive physiological monitoring. Participants wore the device daily for the 23-week study period and had access to their own data through the accompanying mobile application. Daily metrics collected included nightly heart rate variability (rMSSD), sleep score, readiness score, lowest nightly heart rate, a resting heart rate contributor score, and a daytime stress score. No feedback or coaching beyond the device's standard consumer application was provided as part of this intervention. | Device | Wearable ring only (control), Wearable ring plus AI health coaching application, Wearable ring plus AI health coaching application plus OMT |
| AI health coaching applicationAlso: Ziva Health AI health coachA smartphone-based artificial intelligence health coaching application that delivered daily reflection prompts, guided breathing exercises, and individualized behavioral suggestions informed by wearable ring data. Daily engagement was encouraged but was neither incentivized nor enforced, and adherence was not a condition of participation. A major application update was released approximately midway through the study following reported usability problems. | Behavioural | Wearable ring plus AI health coaching application, Wearable ring plus AI health coaching application plus OMT |
| Osteopathic manipulative treatment (OMT)Also: Osteopathic manipulative medicine (OMM)Seven protocoled sessions of osteopathic manipulative treatment delivered by physicians board-certified in Osteopathic Neuromusculoskeletal Medicine, each lasting no longer than 30 minutes, from early January to early May on an approximately three-week schedule with five days of permitted flexibility. Each session began with a TART screening examination (tissue texture change, asymmetry, restriction of motion, tenderness) with passive range-of-motion assessment of the diaphragms, spine, ribs, and extremities, plus cranial vault hold assessment. Every participant then received the same six-technique core sequence addressing autonomic and circulatory targets: suboccipital release, rib raising, sacral rocking, and myofascial release of the thoracic inlet, thoraco-abdominal diaphragm, and pelvis. Physicians then treated the most significant remaining somatic dysfunction using techniques from a specified set. | Other | Wearable ring plus AI health coaching application plus OMT |
Primary outcome
Change in resilience, measured by the Hardiness Resilience Gauge (HRG) Total Hardiness T-score
Time frame: Baseline, Month 3, and Month 6 (end of study)
Standardized T-score derived from the Hardiness Resilience Gauge, reported in a standard score metric with a population mean of 100 and standard deviation of 15. Higher scores indicate greater psychological hardiness; the instrument's average range is 90 to 110. Total Hardiness is reported here; the Challenge, Control, and Commitment subscales are reported as secondary outcome measures.
Change in mood symptoms, measured by the Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Baseline, Month 3, and Month 6 (end of study)
Three subscale scores (Depression, Anxiety, Stress). Each subscale is the sum of 7 items rated 0 to 3, multiplied by 2, giving a range of 0 to 42 per subscale. Higher scores indicate greater symptom severity.
7 secondary outcomes
Change in nightly heart rate variability
Time frame: Daily from baseline through month 6
Change in device-derived daytime stress score
Time frame: Daily from baseline through month 6
Change in sleep score
Time frame: Daily from baseline through month 6
Change in readiness score
Time frame: Daily from baseline through month 6
Change in lowest nightly heart rate
Time frame: Daily from baseline through month 6
Change in resting heart rate contributor score
Time frame: Daily from baseline through month 6
Participant-reported tool use and perceived effectiveness after study completion
Time frame: 2 months and 7 months after study completion
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. Individual participant data will not be made available to external researchers because informed consent for data sharing was not obtained from study participants.
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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.
Nicole J Pena, DO principal investigator
Touro University California College of Osteopathic 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 Wearable ring with continuous biometric monitoring, AI health coaching application and Osteopathic manipulative treatment (OMT) in people with Stress (Psychology) and Resilience, Psychological, run by Touro University, California at 1 site in United States.
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 6 inclusion and 2 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 United States. 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 resilience, measured by the Hardiness Resilience Gauge (HRG) Total Hardiness T-score (time frame: Baseline, Month 3, and Month 6 (end of study)). 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.