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Clinical Trials/NCT03602482
NCT03602482CompletedNot Applicable

Standing Cognition and Co-morbidities of POTS Evaluation

Milton S. Hershey Medical Center1 site in 1 country139 target enrollmentStarted: June 23, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
139
Locations
1
Primary Endpoint
Executive Function (Stroop Word-color Test)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
13 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Standing

Experimental

Participants will complete cognitive testing while standing.

Intervention: Standing (Behavioral)

Supine

Active Comparator

Participants will complete cognitive testing while supine.

Intervention: Supine (Behavioral)

Outcomes

Primary Outcomes

Executive Function (Stroop Word-color Test)

Time Frame: 1 hour

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.

Secondary Outcomes

  • Attention Score Using Cogstate Identification Task(1 hour)
  • Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)(1 hour)
  • Heart Rate Standing Minus Heart Rate Supine(1 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amanda Miller

Postdoctoral Fellow

Milton S. Hershey Medical Center

Study Sites (1)

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