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NCT06616363 · ClinicalTrials.gov registry record

Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?

A clinical trial of POTS - Postural Orthostatic Tachycardia Syndrome, sponsored by Virginia Commonwealth University.

Recruiting
Registry status
120
Enrollment target
1
Study location

NCT06616363 is a study of POTS - Postural Orthostatic Tachycardia Syndrome that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 120 participants, above the 64-participant average among 5 other POTS - Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06616363, a study of POTS - Postural Orthostatic Tachycardia Syndrome, is actively recruiting participants, sponsored by Virginia Commonwealth University.

RECRUITING
Registry status
120 participants
Enrollment target
1
Study location

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2024-05-29
Est. Completion 2028-07

Sponsor

Virginia Commonwealth University

558 total trials

What the Registry Record Tells You About NCT06616363

The ClinicalTrials.gov registry entry for NCT06616363 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 64-participant average among 5 other POTS - Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (88% higher). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.

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.

NCT06616363 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

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.

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).

Who is sponsoring clinical trial NCT06616363?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

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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