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Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
NCT06616363 · View on ClinicalTrials.gov ↗
Study Summary
Postural tachycardia syndrome (POTS) is a common and disabling disorder among adolescents. No epidemiologic data exist to support the often cited 0.5 to 2% prevalence. Case series suggest 3 to 5 times greater incidence in girls than boys. POTS is defined in children as daily chronic symptoms of orthostatic intolerance and a 40 bpm rise in heart rate in the first 10 minutes of a tilt study in the absence of orthostatic hypotension. POTS often develops after an acute event like an illness, infection, immunization, head trauma, psychological trauma or surgery. Natural history data are absent for POTS, though some outcome studies exist. Orthostatic symptoms improve in the majority and heart rate changes improve in 38% at 1 year. A 2-year follow up showed small improvement in comorbid symptoms of POTS in a 12 subject cohort followed yearly. In a pediatric 5-year outcome follow up questionnaire study, 86% of adolescents with POTS reported resolved, improved, or intermittent, symptoms, with primarily physical rather than mental health complaints.
Conditions Studied
Interventions
- BEHAVIORAL Questionnaires to be competed
- BEHAVIORAL Provide list of medication and lifetime events
- BEHAVIORAL Use phone App to record new life events
- DEVICE Will wear an activity monitor
- OTHER Periodic 24-hour urine sodium check
Study Locations (1)
Virginia
- Virginia Commonwealth University — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2028-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06616363
The ClinicalTrials.gov registry entry for NCT06616363 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 513 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with POTS - Postural Orthostatic Tachycardia Syndrome appearing as the primary indexed condition, and to 5 interventions — of which Questionnaires to be competed is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06616363 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06616363 about?
NCT06616363 is a clinical study titled "Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?". Postural tachycardia syndrome (POTS) is a common and disabling disorder among adolescents. No epidemiologic data exist to support the often cited 0.5 to 2% prevalence. Case series suggest 3 to 5 times greater incidence in girls than boys. POTS is defined in children as daily chronic symptoms of orth...
What is the current status of trial NCT06616363?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2024-05-29. Estimated completion is 2028-07.
What conditions does trial NCT06616363 study?
This clinical trial studies the following conditions: POTS - Postural Orthostatic Tachycardia Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06616363?
The interventions under investigation include: Questionnaires to be competed (BEHAVIORAL), Provide list of medication and lifetime events (BEHAVIORAL), Use phone App to record new life events (BEHAVIORAL), Will wear an activity monitor (DEVICE), Periodic 24-hour urine sodium check (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06616363?
This trial is sponsored by Virginia Commonwealth University, which has 513 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06616363 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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