The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity (NCT05618067) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity
United States12 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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…
What they're measuring
1
Change in periaqueductal gray region (PAG) activation - looming task
Timeframe: 90 minutes
2
Change in PAG activation - resting
Timeframe: 90 minutes
3
Change in Heart Rate Variability (HRV)
Timeframe: Assessed for 2 days each week for the duration of the study (6 weeks).