Post Traumatic Stress DisorderNCT04076215
Biochemical and Physiological Response to Stressogenic Stimuli
A study testing Stressogenic stimulus and Biobeat smart watch and adhesive biosensor patches. in people with Post Traumatic Stress Disorder, run by Nadav Goldental.
Trial summary
Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Stressogenic stimulus and Biobeat smart watch and adhesive biosensor patches.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Jun 2020
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PTSD diagnosis (excluding controls)
- Proper ability to give informed consent
Who cannot join
- Active oncological/cardiovascular condition
- Dialysis patients
- Active psychotic or suicidal symptoms
- Severe dissociative symptoms
- A traumatic brain injury (TBI) diagnosis
- Pregnancy
About this study
Official title: Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.
The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Stressogenic stimulus, Biobeat smart watch and adhesive biosensor patches.
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stressogenic stimulusBehavioural
Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting
Biobeat smart watch and adhesive biosensor patches.Device
Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.
| Study group | Role | What they receive |
|---|---|---|
| Pariticapnts with PTSD | Experimental | Not described Receives: Behavioral: Stressogenic stimulus; Device: Biobeat smart watch and adhesive biosensor patches. |
| Pariticapnts without PTSD (controls) | Experimental | Not described Receives: Behavioral: Stressogenic stimulus; Device: Biobeat smart watch and adhesive biosensor patches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant differences between groups - HRV
Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups - temperature
Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups - SPO2
Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups - blood pressure
Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups - pulse pressure
Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups -respiratory rate
Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups -stroke volume
Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups -cardiac output
Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in physiological changes between groups - systemic vascular resistance
Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in cortisol levels between groups
Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - C-reactive protein
Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - Interleukin 6
Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide
Significant differences in biochemical changes - N-terminal B-type natriuretic peptide - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - 8-oxo-7
Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine
Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - hexanone
Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - acetic acid
Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - heptane
Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - hexanal
Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - 3-heptanone
Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - hexanoic acid
Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - heptanal
Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - nonanal
Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Significant differences in biochemical changes between groups - glucose
Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadav Goldental
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadav Goldental, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076215
- Sponsor's protocol ID
- 6263-19-SMC
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Biochemical and Physiological Response to Controlled Stressogenic Stimuli
- ClinicalTrials.gov ID
- NCT04076215
- Acronym / sponsor ID
- 6263-19-SMC
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nadav GoldentalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 3 Sep 2019 (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.
Post-traumatic stress disorder (PTSD) is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. A psychiatric diagnosis of PTSD is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. Discernable patterns of stress-related measures may constitute a physiological and biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.
The current study is aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD. Physiological and biochemical data will be collected from participants with and without PTSD using wearable sensors and adhesive biosensor patches. The data will be collected in two conditions: in a neutral, quiet situation, and during and following exposure to controlled stressogenic stimuli.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pariticapnts with PTSD | Experimental | Behavioral: Stressogenic stimulus, Device: Biobeat smart watch and adhesive biosensor patches. |
| Pariticapnts without PTSD (controls) | Experimental | Behavioral: Stressogenic stimulus, Device: Biobeat smart watch and adhesive biosensor patches. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PTSD diagnosis (excluding controls)
- Proper ability to give informed consent
Key exclusion criteria (6 listed)
- Active oncological/cardiovascular condition
- Dialysis patients
- Active psychotic or suicidal symptoms
- Severe dissociative symptoms
- A traumatic brain injury (TBI) diagnosis
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 |
|---|---|---|
| Stressogenic stimulusParticipants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting | Behavioural | Pariticapnts with PTSD, Pariticapnts without PTSD (controls) |
| Biobeat smart watch and adhesive biosensor patches.Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches. | Device | Pariticapnts with PTSD, Pariticapnts without PTSD (controls) |
Primary outcome
Significant differences between groups - HRV
Time frame: 3 hours
Significant differences in Heart Rate Variability - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - temperature
Time frame: 3 hours
Significant differences in physiological changes - body temperature- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - SPO2
Time frame: 3 hours
Significant differences in physiological changes - Saturation SPO2- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - blood pressure
Time frame: 3 hours
Significant differences in physiological changes - continuous blood pressure- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - pulse pressure
Time frame: 3 hours
Significant differences in physiological changes - pulse pressure - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -respiratory rate
Time frame: 3 hours
Significant differences in physiological changes - respiratory rate- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -stroke volume
Time frame: 3 hours
Significant differences in physiological changes - stroke volume- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups -cardiac output
Time frame: 3 hours
Significant differences in physiological changes - cardiac output - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in physiological changes between groups - systemic vascular resistance
Time frame: 3 hours
Significant differences in physiological changes - systemic vascular resistance- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in cortisol levels between groups
Time frame: 3 hours
Significant differences in biochemical changes - cortisol - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - C-reactive protein
Time frame: 3 hours
Significant differences in biochemical changes - C-reactive protein - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - Interleukin 6
Time frame: 3 hours
Significant differences in biochemical changes - Interleukin 6 - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - N-terminal B-type natriuretic peptide
Time frame: 3 hours
Significant differences in biochemical changes - N-terminal B-type natriuretic peptide - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 8-oxo-7
Time frame: 3 hours
Significant differences in biochemical changes - 8-oxo-7- between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 8-dihydro-2'-deoxyguanosine
Time frame: 3 hours
Significant differences in biochemical changes - 8-dihydro-2'-deoxyguanosine - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanone
Time frame: 3 hours
Significant differences in biochemical changes - hexanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - acetic acid
Time frame: 3 hours
Significant differences in biochemical changes - acetic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - heptane
Time frame: 3 hours
Significant differences in biochemical changes - heptane - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanal
Time frame: 3 hours
Significant differences in biochemical changes -hexanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - 3-heptanone
Time frame: 3 hours
Significant differences in biochemical changes - 3-heptanone - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - hexanoic acid
Time frame: 3 hours
Significant differences in biochemical changes - hexanoic acid - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - heptanal
Time frame: 3 hours
Significant differences in biochemical changes -heptanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - nonanal
Time frame: 3 hours
Significant differences in biochemical changes - nonanal - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Significant differences in biochemical changes between groups - glucose
Time frame: 3 hours
Significant differences in biochemical changes - glucose - between groups (participants with PTSD and controls) before and after exposure to stressogenic stimuli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stressogenic stimulus and Biobeat smart watch and adhesive biosensor patches. in people with Post Traumatic Stress Disorder, run by Nadav Goldental.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Significant differences between groups - HRV (time frame: 3 hours). The study lists 24 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 3 Sep 2019.