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| Name | Class |
|---|---|
| Dysautonomia International | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standing | Experimental | Participants will complete cognitive testing while standing. |
|
| Supine | Active Comparator | Participants will complete cognitive testing while supine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standing | Behavioral | Participants will stand and complete cognitive tests. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda J Miller, Ph.D. | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17111 | United States |
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Participants with odd study IDs completed cognitive testing while supine first. Participants with even study IDs completed cognitive testing standing first.
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,
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | POTS | Participants previously diagnosed with postural orthostatic tachycardia syndrome who were able to stand unassisted were enrolled |
| BG001 | Control | Healthy volunteers that were free of chronic illness were enrolled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 13 participants dropped out (by their choice) prior to study visit. Mean and standard deviation scores for each arm are reported. | Posted | Mean | Standard Deviation | Testing Scores | 1 hour |
|
During Study Visit, up to 1 hour
Participants were not followed after study visit for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POTS- Supine | Participants previously diagnosed with postural tachycardia syndrome age 13-60 years. Participants completed supine testing first, then standing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda J. Miller | Pennsylvania State University College of Medicine | 7175317676 | aross1@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078783 | Standing Position |
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Supine |
| Behavioral |
Participants will complete cognitive tests while supine. |
|
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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| education level | Mean | Standard Deviation | years |
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | 13 participants dropped out (by their choice) prior to study visit. Mean and standard deviation scores for each arm are reported. | Posted | Mean | Standard Deviation | reaction time (milliseconds) | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Mean | Standard Deviation | beats/minute | 1 hour |
|
|
|
| 0 |
| 139 |
| 0 |
| 44 |
| 0 |
| 139 |
| EG001 | Control- Supine | Healthy volunteers with no chronic/systemic illness age 13-60 years. Participants completed supine testing first, then standing. | 0 | 139 | 0 | 43 | 0 | 139 |
| EG002 | POTS- Standing | Participants previously diagnosed with postural tachycardia syndrome age 13-60 years. Participants completed standing testing first, then supine. | 0 | 139 | 0 | 20 | 0 | 139 |
| EG003 | Control- Standing | Healthy volunteers with no chronic/systemic illness age 13-60 years.Participants completed standing testing first, then supine. | 0 | 139 | 0 | 19 | 0 | 139 |
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| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| ID test speed supine |
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