Standing Cognition and Co-morbidities of POTS Evaluation

Not Applicable

Completed

• Conditions: Postural Tachycardia Syndrome; Ehlers-Danlos Syndrome
• Interventions: Behavioral: Standing; Behavioral: Supine

• Registration Number: NCT03602482
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-23
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-07-26
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Results First Submitted: 2020-07-21
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-19
• Last Update Submitted: 2021-03-19
• Results First Posted: 2021-04-14
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standing	Standing	Participants will complete cognitive testing while standing.
Supine	Supine	Participants will complete cognitive testing while supine.

Primary Outcome Measures

Name	Time	Method
Executive Function (Stroop Word-color Test)	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 Outcome Measures

Name	Time	Method
Attention Score Using Cogstate Identification Task	1 hour	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.
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)	1 hour	hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.
Heart Rate Standing Minus Heart Rate Supine	1 hour	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.

Trial Locations

Locations (1)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States