Trial Outcomes & Findings for Standing Cognition and Co-morbidities of POTS Evaluation (NCT NCT03602482)
NCT ID: NCT03602482
Last Updated: 2021-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
1 hour
Results posted on
2021-04-14
Participant Flow
100 participants with POTS were recruited at the 2018 Dysautonomia International Conference in June 2018 in Nashville, TN. 39 Healthy participants were enrolled at Penn State Hershey Medical Center from August 2018- December 2019,
Participants with odd study IDs completed cognitive testing while supine first. Participants with even study IDs completed cognitive testing standing first.
Participant milestones
| Measure |
POTS- Supine First, Then Standing
Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
|
POTS- Standing First, Then Supine
Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
|
Controls- Supine First, Then Standing
Healthy volunteers with no chronic or systemic illness, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
|
Controls- Standing First, Then Supine
Healthy volunteers with no chronic or systemic illness, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
20
|
19
|
|
Overall Study
COMPLETED
|
44
|
43
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
0
|
0
|
Reasons for withdrawal
| Measure |
POTS- Supine First, Then Standing
Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
|
POTS- Standing First, Then Supine
Volunteers previously diagnosed with postural tachycardia syndrome, able to stand unassisted, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
|
Controls- Supine First, Then Standing
Healthy volunteers with no chronic or systemic illness, age 13-60 years. Odd numbered participants assigned to complete cognitive tests in the supine posture first then in the standing posture.
|
Controls- Standing First, Then Supine
Healthy volunteers with no chronic or systemic illness, age 13-60 years. Even numbered participants assigned to complete cognitive tests in the standing posture first, then supine.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
0
|
0
|
Baseline Characteristics
Standing Cognition and Co-morbidities of POTS Evaluation
Baseline characteristics by cohort
| Measure |
POTS
n=100 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted were enrolled
|
Control
n=39 Participants
Healthy volunteers that were free of chronic illness were enrolled
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
27 years
n=99 Participants
|
24 years
n=107 Participants
|
25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=99 Participants
|
39 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
education level
|
15 years
STANDARD_DEVIATION 3 • n=99 Participants
|
16 years
STANDARD_DEVIATION 2 • n=107 Participants
|
15 years
STANDARD_DEVIATION 3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: 13 participants dropped out (by their choice) prior to study visit. Mean and standard deviation scores for each arm are reported.
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.
Outcome measures
| Measure |
POTS- Supine, Standing
n=44 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
POTS- Standing, Supine
n=43 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
Control- Supine, Standing
n=20 Participants
Healthy volunteers that were free of chronic illness. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
Control- Standing, Supine
n=19 Participants
Healthy volunteers, free of chronic illness. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
|---|---|---|---|---|
|
Executive Function (Stroop Word-color Test)
Supine Stroop Scores
|
45 Testing Scores
Standard Deviation 10
|
54 Testing Scores
Standard Deviation 12
|
55 Testing Scores
Standard Deviation 10
|
56 Testing Scores
Standard Deviation 10
|
|
Executive Function (Stroop Word-color Test)
Standing Stroop Scores
|
48 Testing Scores
Standard Deviation 13
|
49 Testing Scores
Standard Deviation 10
|
50 Testing Scores
Standard Deviation 6
|
58 Testing Scores
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 1 hourPopulation: 13 participants dropped out (by their choice) prior to study visit. Mean and standard deviation scores for each arm are reported.
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.
Outcome measures
| Measure |
POTS- Supine, Standing
n=44 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
POTS- Standing, Supine
n=43 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
Control- Supine, Standing
n=20 Participants
Healthy volunteers that were free of chronic illness. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
Control- Standing, Supine
n=19 Participants
Healthy volunteers, free of chronic illness. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
|---|---|---|---|---|
|
Attention Score Using Cogstate Identification Task
ID test speed standing
|
2.78 reaction time (milliseconds)
Standard Deviation 0.11
|
2.78 reaction time (milliseconds)
Standard Deviation 0.12
|
2.70 reaction time (milliseconds)
Standard Deviation 0.05
|
2.68 reaction time (milliseconds)
Standard Deviation 0.06
|
|
Attention Score Using Cogstate Identification Task
ID test speed supine
|
2.74 reaction time (milliseconds)
Standard Deviation 0.09
|
2.64 reaction time (milliseconds)
Standard Deviation 0.40
|
2.71 reaction time (milliseconds)
Standard Deviation 0.06
|
2.70 reaction time (milliseconds)
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: 1 hourPopulation: The number of participants who had hEDS are reported. This assessment was performed without respect to position (standing/supine) and only in POTS participants. Nine POTS participants did not complete this portion of the study. Healthy controls were not included in this outcome measure.
hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.
Outcome measures
| Measure |
POTS- Supine, Standing
n=91 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
POTS- Standing, Supine
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
Control- Supine, Standing
Healthy volunteers that were free of chronic illness. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
Control- Standing, Supine
Healthy volunteers, free of chronic illness. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
|---|---|---|---|---|
|
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)
|
28 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hourPopulation: The change in heart rate (HR standing - HR supine) was calculated for each participant. Mean and standard deviation changes in heart rate (standing HR - supine HR) are reported for each study arm.
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.
Outcome measures
| Measure |
POTS- Supine, Standing
n=87 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
POTS- Standing, Supine
n=39 Participants
Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
Control- Supine, Standing
Healthy volunteers that were free of chronic illness. Odd numbered participants were assigned to cognitive testing in the supine posture first, then in the standing posture.
|
Control- Standing, Supine
Healthy volunteers, free of chronic illness. Even numbered participants were assigned to cognitive testing in the standing posture first, then in the supine posture.
|
|---|---|---|---|---|
|
Heart Rate Standing Minus Heart Rate Supine
|
15 beats/minute
Standard Deviation 10
|
12 beats/minute
Standard Deviation 8
|
—
|
—
|
Adverse Events
POTS- Supine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control- Supine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
POTS- Standing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control- Standing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amanda J. Miller
Pennsylvania State University College of Medicine
Phone: 7175317676
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place