HypertensionSPIRITNCT05971433
Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation
An observational study of Hypertension and Cardiovascular Diseases, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the long-term health of United States military service members who were injured during combat. The main questions it aims to examine are: How does the severity of a combat injury impact 1) cardiovascular risk, 2) the sympathetic nervous system and arrhythmias, 3)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Sleep Disorder
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Wounded Warrior Recovery Project participants who 1) agreed to be contacted about future research studies and 2) have a record of injury within the established Injury Severity Score cutoffs for this study
Who may be able to join
- Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be contacted regarding future research
- Able to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
- Age greater than or equal to 18 years
Who cannot join
- No Injury Severity Score or 3 < Injury Severity Score < 15
- Unable to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
- Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted about future research
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
About this study
Official title: Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)
The goal of this observational study is to learn about the long-term health of United States military service members who were injured during combat. The main questions it aims to examine are:
- How does the severity of a combat injury impact 1) cardiovascular risk, 2) the sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders?
- Are self-reported mental health symptoms related to sympathetic nervous system hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service members?
Read more
This study will recruit from a sample of participants in another research study called the Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research studies and 2) have a record of a combat injury within the Injury Severity Score ranges required for this study.
Participants will:
- Provide demographic information and a medical history review
- Visit a local laboratory for biometrics measurements and to provide blood and urine samples
- Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive days
- Wear a home sleep test monitoring device for one night
- Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep test
At the end of the study, participants will be asked to mail back the home sleep test and blood pressure monitors. Prepaid package materials will be provided.
- Conditions
- Hypertension, Cardiovascular Diseases, Sleep Disorder, Arrythmia, Sympathetic Nervous System, Injury Traumatic
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Sleep Wake Disorders, Arrhythmias, Cardiac, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Injury severity scored as "severe" | This group will include participants whose injury was scored as "severe" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study. | |
| Injury severity scored as "minimal" | This group will include participants whose injury was scored as "minimal" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of arrhythmias
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
Measured: 7 days of wear
Frequency of atrial fibrillation
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.
Measured: 7 days of wear
Frequency of atrial flutter
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.
Measured: 7 days of wear
Density of premature ventricular contractions (PVCs)
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the density of PVCs (percentage of total heartbeats that are PVCs).
Measured: 7 days of wear
Frequency of ventricular tachycardia
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.
Measured: 7 days of wear
Heart rate
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.
Measured: 7 days of wear
Standard deviation of beat-to-beat intervals (SDNN)
Standard deviation of beat-to-beat intervals (SDNN) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
Root mean square of successive differences (RMSSD)
Root mean square of successive differences (RMSSD) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
Low frequency power
Low frequency power (LF, 0.04 - 0.15 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
High frequency power
High frequency power (HF, 0.15 - 0.4 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
Log-transformed QT variance (logQTv)
Log-transformed QT variance (logQTv) s a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
Beat-to-beat QT variability index (QTVI)
Beat-to-beat QT variability index (QTVI) is a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Measured: 7 days of wear
Presence of obstructive sleep apnea
The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
Measured: One night
Presence of nocturnal hypoxemia
The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
Measured: One night
24-hour ambulatory blood pressure monitor (ABPM)
Blood pressure (diastolic and systolic) will be assessed using a 24-hour ABPM worn during the 24-hour period following the HST.
Measured: 24 hours
High sensitivity C-reactive protein (hs-CRP)
This inflammatory marker will be measured during laboratory testing.
Measured: Baseline
Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)
The severity of Posttraumatic Stress Disorder (PTSD) symptoms will be assessed by the PCL-5 20-question survey. Total scores range from 0 - 80, with higher scores indicating greater PTSD symptom severity.
Measured: Baseline
8-item Patient Health Questionnaire depression scale (PHQ-8)
The severity of depressive symptoms will be measured by the eight-question PHQ-8 survey. Total scores range from 0 - 24, with with higher scores indicating greater depressive symptom severity.
Measured: Baseline
Brief Dissociative Experience Scale (DES-B)
Severity of dissociative experiences will be assessed using the 8-item DES-B survey. Total scores range from 0 - 32, with with higher scores indicating greater dissociative experience severity.
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Participant-reported sleep characteristics will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 - 21, with higher scores indicating worse sleep quality.
Measured: Baseline
Epworth Sleepiness Scale (ESS)
Participant-reported sleep characteristics will be assessed using the 8-item Epworth Sleepiness Scale (ESS). Total scores range from 0 - 24, with higher scores indicating increased daytime sleepiness.
Measured: Baseline
Insomnia Severity Index (ISI)
Participant-reported sleep characteristics will be assessed using the 7-item Insomnia Severity Index (ISI). Total scores range from 0 - 28, with higher scores indicating increased insomnia symptoms.
Measured: Baseline
Berlin Sleep Questionnaire
Participant-reported sleep characteristics will be assessed using the 11-item Berlin Sleep Questionnaire. Scores will be calculated to determine if participants are "High Risk" or "Low Risk" for sleep apnea.
Measured: Baseline
Body Mass Index
Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.
Measured: Baseline
Blood Pressure
Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit
Measured: Baseline
Hemoglobin A1C (HBA1C)
This laboratory test will be used to assess overall health outcomes.
Measured: Baseline
Alanine aminotransferase (ALT/SGPT)
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Albumin:globulin (A:G) ratio
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Albumin, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Alkaline phosphatase, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Aspartate aminotransferase (AST/SGOT)
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Bilirubin, total
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Blood urea nitrogen (BUN)
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Blood urea nitrogen (BUN):creatinine ratio
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Calcium, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Carbon dioxide, total
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Chloride, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Creatinine, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Estimated glomerular filtration rate (eGFR) calculation
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Globulin, total
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Glucose, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Potassium, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Protein, total, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Sodium, serum
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Measured: Baseline
Cystatin C with estimated glomerular filtration rate (eGFR)
This laboratory test will be used to assess overall health outcomes.
Measured: Baseline
Cholesterol, total
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Measured: Baseline
High-density lipoprotein (HDL) cholesterol
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Measured: Baseline
Low-density lipoprotein (LDL) cholesterol (calculation)
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Measured: Baseline
Triglycerides
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Measured: Baseline
Very low-density lipoprotein (VLDL) cholesterol (calculation)
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Measured: Baseline
Albumin/creatinine ratio, random urine
This laboratory test will be used to assess overall health outcomes.
Measured: Baseline
N-terminal pro b-type natriuretic peptide (NT-proBNP)
This laboratory test will be used to assess overall health outcomes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Apr 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Naval Health Research Center
- Responsible party
- Principal investigator, Soroosh Solhjoo, PhD, Uniformed Services University of the Health Sciences
- Investigators
- Soroosh Solhjoo, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971433
- Sponsor's protocol ID
- USUHS.2022-110
- Acronym
- SPIRIT
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walker LE, Jurick SM, Thomas V, Arnold T, Elisman K, Kalra S, Mains A, Rioux S, Galarneau M, McCabe C, Lavender JM, Collen J, Haigney MC, Solhjoo S, Stewart IJ. A study protocol for determining the role of Sympathetic activity in Post-injury outcomes: Impact on sleep and caRdiovascular health InvesTigation (SPIRIT). PLoS One. 2025 Jul 17;20(7):e0321035. doi: 10.1371/journal.pone.0321035. eCollection 2025.
PubMed 40674309
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Role of Sympathetic Activity in the Impact of Combat Injury on Sleep and Cardiovascular Outcomes (SPIRIT)
- ClinicalTrials.gov ID
- NCT05971433
- Acronym / sponsor ID
- SPIRIT / USUHS.2022-110
- Conditions
- Hypertension, Cardiovascular Diseases, Sleep Disorder, Arrythmia, Sympathetic Nervous System, Injury Traumatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Naval Health Research Center
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Aug 2023 (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 observational study is to learn about the long-term health of United States military service members who were injured during combat. The main questions it aims to examine are:
- How does the severity of a combat injury impact 1) cardiovascular risk, 2) the sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders?
- Are self-reported mental health symptoms related to sympathetic nervous system hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service members?
This study will recruit from a sample of participants in another research study called the Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research studies and 2) have a record of a combat injury within the Injury Severity Score ranges required for this study.
Participants will:
- Provide demographic information and a medical history review
- Visit a local laboratory for biometrics measurements and to provide blood and urine samples
- Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive days
- Wear a home sleep test monitoring device for one night
- Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep test
At the end of the study, participants will be asked to mail back the home sleep test and blood pressure monitors. Prepaid package materials will be provided.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injury severity scored as "severe" | – | –This group will include participants whose injury was scored as "severe" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study. |
| Injury severity scored as "minimal" | – | –This group will include participants whose injury was scored as "minimal" based on the recorded Injury Severity Score (ISS). Both cohorts will complete the same course of testing in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wounded Warrior Recovery Project participants who 1) agreed to be contacted about future research studies and 2) have a record of injury within the established Injury Severity Score cutoffs for this study
Key inclusion criteria (3 listed)
- Enrolled in the Wounded Warrior Recovery Project (WWRP) and previously agreed to be contacted regarding future research
- Able to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
- Age greater than or equal to 18 years
Key exclusion criteria (3 listed)
- No Injury Severity Score or 3 < Injury Severity Score < 15
- Unable to complete the informed consent process, be mailed study devices, and complete laboratory draws within the United States
- Not enrolled in the WWRP or enrolled in the WWRP but did not agree to be contacted about future research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of arrhythmias
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of arrhythmias.
Frequency of atrial fibrillation
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial fibrillation.
Frequency of atrial flutter
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of atrial flutter.
Density of premature ventricular contractions (PVCs)
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the density of PVCs (percentage of total heartbeats that are PVCs).
Frequency of ventricular tachycardia
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine the frequency of ventricular tachycardia.
Heart rate
Time frame: 7 days of wear
Readings from a 24-hour ambulatory electrocardiogram (ECG) monitor will be used to determine heart rate.
Standard deviation of beat-to-beat intervals (SDNN)
Time frame: 7 days of wear
Standard deviation of beat-to-beat intervals (SDNN) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Root mean square of successive differences (RMSSD)
Time frame: 7 days of wear
Root mean square of successive differences (RMSSD) is a heart rate variability (HRV) time domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Low frequency power
Time frame: 7 days of wear
Low frequency power (LF, 0.04 - 0.15 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
High frequency power
Time frame: 7 days of wear
High frequency power (HF, 0.15 - 0.4 Hz) is a heart rate variability (HRV) frequency domain measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Log-transformed QT variance (logQTv)
Time frame: 7 days of wear
Log-transformed QT variance (logQTv) s a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Beat-to-beat QT variability index (QTVI)
Time frame: 7 days of wear
Beat-to-beat QT variability index (QTVI) is a QT variability (QTV) measure that will be automatically calculated for each 5-min epoch of the 24-hour ambulatory electrocardiogram (ECG) recording.
Presence of obstructive sleep apnea
Time frame: One night
The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
Presence of nocturnal hypoxemia
Time frame: One night
The presence of comorbid obstructive sleep apnea and/or nocturnal hypoxemia, will be evaluated with a home sleep study test device (HST) worn during the second or third study day
24-hour ambulatory blood pressure monitor (ABPM)
Time frame: 24 hours
Blood pressure (diastolic and systolic) will be assessed using a 24-hour ABPM worn during the 24-hour period following the HST.
High sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline
This inflammatory marker will be measured during laboratory testing.
Posttraumatic Stress Disorder Checklist for Diagnostic and Statistics Manual of Mental Disorder 5 (PCL-5)
Time frame: Baseline
The severity of Posttraumatic Stress Disorder (PTSD) symptoms will be assessed by the PCL-5 20-question survey. Total scores range from 0 - 80, with higher scores indicating greater PTSD symptom severity.
8-item Patient Health Questionnaire depression scale (PHQ-8)
Time frame: Baseline
The severity of depressive symptoms will be measured by the eight-question PHQ-8 survey. Total scores range from 0 - 24, with with higher scores indicating greater depressive symptom severity.
Brief Dissociative Experience Scale (DES-B)
Time frame: Baseline
Severity of dissociative experiences will be assessed using the 8-item DES-B survey. Total scores range from 0 - 32, with with higher scores indicating greater dissociative experience severity.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Participant-reported sleep characteristics will be assessed using the 19-item Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 - 21, with higher scores indicating worse sleep quality.
Epworth Sleepiness Scale (ESS)
Time frame: Baseline
Participant-reported sleep characteristics will be assessed using the 8-item Epworth Sleepiness Scale (ESS). Total scores range from 0 - 24, with higher scores indicating increased daytime sleepiness.
Insomnia Severity Index (ISI)
Time frame: Baseline
Participant-reported sleep characteristics will be assessed using the 7-item Insomnia Severity Index (ISI). Total scores range from 0 - 28, with higher scores indicating increased insomnia symptoms.
Berlin Sleep Questionnaire
Time frame: Baseline
Participant-reported sleep characteristics will be assessed using the 11-item Berlin Sleep Questionnaire. Scores will be calculated to determine if participants are "High Risk" or "Low Risk" for sleep apnea.
Body Mass Index
Time frame: Baseline
Height and weight will be measured during laboratory visit and combined to report BMI in kg/m^2.
Blood Pressure
Time frame: Baseline
Blood pressure (diastolic and systolic) will be recorded at the time of laboratory visit
Hemoglobin A1C (HBA1C)
Time frame: Baseline
This laboratory test will be used to assess overall health outcomes.
Alanine aminotransferase (ALT/SGPT)
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Albumin:globulin (A:G) ratio
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Albumin, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Alkaline phosphatase, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Aspartate aminotransferase (AST/SGOT)
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Bilirubin, total
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Blood urea nitrogen (BUN)
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Blood urea nitrogen (BUN):creatinine ratio
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Calcium, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Carbon dioxide, total
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Chloride, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Creatinine, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Estimated glomerular filtration rate (eGFR) calculation
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Globulin, total
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Glucose, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Potassium, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Protein, total, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Sodium, serum
Time frame: Baseline
This laboratory test will be measured as part of a comprehensive metabolic panel and will be used to assess overall health outcomes.
Cystatin C with estimated glomerular filtration rate (eGFR)
Time frame: Baseline
This laboratory test will be used to assess overall health outcomes.
Cholesterol, total
Time frame: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
High-density lipoprotein (HDL) cholesterol
Time frame: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Low-density lipoprotein (LDL) cholesterol (calculation)
Time frame: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Triglycerides
Time frame: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Very low-density lipoprotein (VLDL) cholesterol (calculation)
Time frame: Baseline
This laboratory test will be measured as part of a lipid panel and will be used to assess overall health outcomes.
Albumin/creatinine ratio, random urine
Time frame: Baseline
This laboratory test will be used to assess overall health outcomes.
N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time frame: Baseline
This laboratory test will be used to assess overall health outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 40674309Walker LE, Jurick SM, Thomas V, Arnold T, Elisman K, Kalra S, Mains A, Rioux S, Galarneau M, McCabe C, Lavender JM, Collen J, Haigney MC, Solhjoo S, Stewart IJ. A study protocol for determining the role of Sympathetic activity in Post-injury outcomes: Impact on sleep and caRdiovascular health InvesTigation (SPIRIT). PLoS One. 2025 Jul 17;20(7):e0321035. doi: 10.1371/journal.pone.0321035. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Soroosh Solhjoo, PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Diseases, run by Uniformed Services University of the Health Sciences 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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of arrhythmias (time frame: 7 days of wear). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05971433, which also lists 1 linked publication.
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 13 Oct 2026.