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NCT02167412 · ClinicalTrials.gov registry record
EEG Characteristics in Youth POTS and/or Syncope
A clinical trial, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- 80
- Enrollment target
NCT02167412: Completed study, sponsored by Nationwide Children's Hospital.
NCT02167412 is a clinical trial that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02167412 has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. This study will compare EEG characteristics and sweat rate during head-upright tilt (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and lower extremity compression. The primary aim of this study is to characterize video EEG changes that correspond with orthostatic intolerance in youth during HUT testing. The investigators hypothesize that the clinical encephalopathy related to POTS and referred to as 'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2) correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG characteristics that distinguish syncope with POTS from syncope without POTS. The investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to syncope patients without POTS) which are protective of syncope during daily activities.
Primary Outcome
Video EEG characteristics of orthostatic intolerance symptoms related to POTS (with and without syncope) and to syncope (without POTS) will be identified and compared between POTS and syncope cohorts.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-05 |
What the finished NCT02167412 record still lists
NCT02167412 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02167412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02167412 about?
NCT02167412 is a clinical study titled "EEG Characteristics in Youth POTS and/or Syncope". Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. This study will compare EEG ...
What is the current status of trial NCT02167412?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2014-06. Estimated completion is 2016-05.
Who is sponsoring clinical trial NCT02167412?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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