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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03602482
Other study ID # Study00009606
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 23, 2018
Est. completion date December 17, 2019

Study information

Verified date March 2021
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate cognition in patients with postural tachycardia syndrome (POTS) while lying down and standing and to assess the prevalence of hypermobile Ehlers-Danlos Syndrome in POTS.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date December 17, 2019
Est. primary completion date December 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 60 Years
Eligibility Inclusion Criteria: - Previously diagnosed with POTS, or healthy control - Age between 13-60 years - Participants may be any race, ethnicity, sex, or gender - Able and willing to provide informed consent Exclusion Criteria: - Inability to give, or withdrawal of, informed consent - Age = 13 or = 61 years - Prisoners - Unable to stand

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standing
Participants will stand and complete cognitive tests.
Supine
Participants will complete cognitive tests while supine.

Locations

Country Name City State
United States Penn State College of Medicine Hershey Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center Dysautonomia International

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Executive Function (Stroop Word-color Test) Testing scores are normalized using T-scores for predicted values based on age and education for each participant. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing. 1 hour
Secondary Attention Score Using Cogstate Identification Task Scores are measured as speed to complete task with lower numbers indicating faster reaction time. Testing will be performed while participants are supine and standing. 1 hour
Secondary Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS) hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported. 1 hour
Secondary Heart Rate Standing Minus Heart Rate Supine Heart rate (HR) will be measured using an arm blood pressure cuff while participants are in supine and standing postures. The difference in heart rate (HR standing - HR supine) was calculated for each participant. 1 hour
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