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Postural Tachycardia SyndromeNCT05618067

The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

A study testing breathing exercise training in people with Postural Tachycardia Syndrome, run by Virginia Commonwealth University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Postural Tachycardia Syndrome
What is being tested?
breathing exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Jan 2028to Dec 2028
Phase
Interventional
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18-50 years
  • Diagnosis of POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
  • Can speak and read in English
  • Upcoming new patient VCU Comprehensive Autonomics Center clinic visit scheduled at least 1 week in the future

Who cannot join

  • Inflammatory arthritis, connective tissue or auto-immune disorder
  • Any chronic neurological disorder besides POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
  • Patients who have already had a new patient clinic visit where they were exposed to breathing exercise education
  • Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
  • Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
  • Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
Show all 14Show fewer
  • Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
  • Current substance or alcohol abuse
  • Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
  • Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
  • Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
  • Chronic use of narcotics for pain
  • Claustrophobia or any metal hardware that may interfere with MRI
  • Investigators and study staff

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas Chelimsky, M.D. contact

(804)-628-0145

thomas.chelimsky@vcuhealth.org

Madison Maxwell, B.S. contact

maxwellme@vcu.edu

United States1 site
  • Virnigia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.

Being tested
breathing exercise training
Medical subject headings
Postural Orthostatic Tachycardia Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • breathing exercise trainingBehavioural

    Participants will engage in weekly breathing exercises. They will be trained once a week for 4 weeks, and will use an app called Inner Balance and an device called Firstbeat Bodyguard 3 to track data about their hearts while practicing the exercises at home for 10 minutes a day, twice a day, once before bedtime.

Study groups in NCT05618067
Study groupRoleWhat they receive
TrainingExperimentalNot described
Receives: Behavioral: breathing exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in periaqueductal gray region (PAG) activation - looming task

    Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region during the looming task

    Measured: 90 minutes

  2. Change in PAG activation - resting

    Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest

    Measured: 90 minutes

  3. Change in Heart Rate Variability (HRV)

    HRV will be measured using an ear clip and/or wristband and results will be recorded automatically in the app

    Measured: Assessed for 2 days each week for the duration of the study (6 weeks).

Secondary outcomes (10)
  1. Change in Fatigue Severity Scale (FSS) score from baseline

    The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue by asking participants to answer 9 statements that rate the severity of their fatigue symptoms in the past week by selecting their answer on a 1-7 point Likert scale. Sum scores range from 9-36. A low value (e.g., 1) indicates strong disagreement with the statement (lower symptom severity), whereas a high value (e.g., 7) indicates strong agreement (higher symptom severity).

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  2. Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline

    The Generalized Anxiety Disorder Scale (GAD-2) is a method of evaluating anxiety symptoms by asking participants to answer 2 statements that rate the severity of their anxiety symptoms in the past 2 weeks by selecting their answer a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-6. A low value (e.g., 0) indicates no or less severe anxiety symptoms, whereas a high value (e.g. 3), indicates more severe anxiety symptoms.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  3. Differences in Adverse Childhood Experiences (ACE) scores between participants

    The Adverse Childhood Experiences (ACE) questionnaire is a method of evaluating childhood adversities such as emotional, physical, and sexual abuse/neglect by asking participants to answer 10 statements that describe events that happened during the first 18 years of their life. Participants indicate if this event occurred by selecting a Yes or No answer. Sum scores range from 0-10. Less "Yes" responses indicate less ACE occurrences, and more "Yes" responses indicate more ACE occurrences.

    Measured: Assessed at baseline.

  4. Change in Pain Catastrophizing Scale (PCS) score from baseline

    The Pain Catastrophizing Scale (PCS) is a method of evaluating pain catastrophizing, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification by asking participants to answer 13 items that describe different thoughts and feelings that may be associated with their pain. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  5. Change in Patient Health Questionnaire (PHQ-9) score from baseline

    The Patient Health Questionnaire (PHQ-9) objectifies and assesses degree of depression severity via questionnaire by asking participants to answer 9 items that rate the severity of depression symptoms over the past 2 weeks on a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-36. A low value (e.g., 0) indicates no or less severe depression symptoms, whereas a high value (e.g. 3), indicates more severe depression symptoms.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  6. Change in Pittsburgh Sleep Quality Index (PSQI) from baseline

    The Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the past month. Participants are asked to answer 19 items. 5 items are free response and ask questions about sleep duration. The remaining 14 items are answered on a 0-3 point Likert scale (0 - not during the past month, 1- less than once a week, 2- once or twice a week, 3- three or more times a week) that describe the frequency of the listed events. A global score is calculated from the sum of 7 component scores and ranges from 0-21, with lower scores indicating lower sleep dysfunction and higher scores indicating higher sleep dysfunction.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  7. Change in PROMIS Physical Function (PROMIS 8b) from baseline

    The PROMIS Physical Function (PROMIS 8b) instrument measures self-reported capability of physical activities by asking participants to respond to 8 items on a 5-point Likert scale. The scale for the first 4 items is as follows: 5- Without any difficulty, 4- With a little difficulty, 3- With some difficulty, 2- With much difficulty, 1- Unable to do. The scale for the last 4 items is as follows: 5- Not at all, 4- Very little, 3- Somewhat, 2- Quite a lot, 1- Cannot do. Raw sum scores range from 8-40 and are converted into a T-score ranging from 20.3 to 60.1, with higher scores indicating better physical function and lower scores indicating poorer physical function.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  8. Change in the Perceived Stress Scale (PSS) from baseline

    The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. Participants are asked to answer 10 items that describe the frequency of their feelings and thoughts described in each item during the last month on a 0-4 point Likert scale (0 - never, 1- almost never, 2- sometimes, 3- fairly often, 4- very often). Sum scores range from 0-40, with lower scores indicating less perceived stress levels and higher scores indicating higher perceived stress levels.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  9. Change in the PTSD Checklist (PCL-5) from baseline

    The PCL-5 assesses the 20 DSM-5 symptoms of PTSD. Participants are asked to answer 5 free response questions about the worst \& more stressful event to which they were exposed, then 20 items about the event on a 0-4 point Likert scale (0- not at all, 1- a little bit, 2- moderately, 3- quite a bit, 4- extremely). Sum scores of the 20 Likert-format items range from 0-80, with lower scores indicating less severe PTSD symptoms and higher scores indicating more severe PTSD symptoms.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

  10. Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline

    The Pain, Enjoyment of Life, and General Activity (PEG-3) scale assesses pain levels and interference with enjoyment of life and activity. Participants are asked to answer 3 items on a 0-10 point Likert scale. For item 1, the scale is as follows: 0- no pain, 10- pain as bad as you can imagine. For items 2-3, the scale is as follows: 0- does not interfere, 10- completely interferes. Sum scores range from 0-30, with lower scores indicating less pain and/or interference and higher scores indicating more pain and/or interference.

    Measured: Assessed at baseline, week 3, and week 6 (final visit).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study startJan 2028 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05618067
Sponsor's protocol ID
HM20025315
Status last verified
Sep 2026
First submitted
9 Nov 2022
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing breathing exercise training in people with Postural Tachycardia Syndrome, run by Virginia Commonwealth University 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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 16 Sep 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?

Contact Thomas Chelimsky, M.D. ((804)-628-0145, thomas.chelimsky@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in periaqueductal gray region (PAG) activation - looming task (time frame: 90 minutes). The study lists 3 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 16 Sep 2026.

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