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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: Recruiting study of POTS - Postural Orthostatic Tachycardia Syndrome, sponsored by Virginia Commonwealth University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. There are 15-items and a score of 0 indicates that there are no complaints present whereas 30 indicates that the patient is extremely disabled. The Functional Disability Inventory (FDI) is one of the most widely used measures of functional impairment among children and adolescents with chronic pain. It is expected that there will be higher threat sensitivity that correla
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 |
What NCT06616363 shows while recruiting
NCT06616363 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 64-participant average among 5 other POTS - Postural Orthostatic Tachycardia Syndrome trials with a reported enrollment target (88% higher).
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 a single indexed study location in 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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