Postural Tachycardia SyndromeSCOPENCT03602482
Standing Cognition and Co-morbidities of POTS Evaluation
A study testing Standing and Supine in people with Postural Tachycardia Syndrome and Ehlers-Danlos Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome, Ehlers-Danlos Syndrome
- What is being tested?
- Standing and Supine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2018to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Inability to give, or withdrawal of, informed consent
- Age ≤ 13 or ≥ 61 years
- Prisoners
- Unable to stand
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17111
About this study
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.
- Being tested
- Standing, Supine
- Keywords
- postural tachycardia syndrome, cognition
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandingBehavioural
Participants will stand and complete cognitive tests.
SupineBehavioural
Participants will complete cognitive tests while supine.
| Study group | Role | What they receive |
|---|---|---|
| Standing | Experimental | Participants will complete cognitive testing while standing. Receives: Behavioral: Standing |
| Supine | Active comparator | Participants will complete cognitive testing while supine. Receives: Behavioral: Supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (3)
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.
Measured: 1 hour
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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start23 Jun 2018
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dysautonomia International
- Responsible party
- Principal investigator, Amanda Miller, Milton S. Hershey Medical Center
- Investigators
- Amanda J Miller, Ph.D., Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602482
- Sponsor's protocol ID
- Study00009606
- Acronym
- SCOPE
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2018
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standing Cognition and Co-morbidities of POTS Evaluation
- ClinicalTrials.gov ID
- NCT03602482
- Acronym / sponsor ID
- SCOPE / Study00009606
- Keywords
- postural tachycardia syndrome, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Dysautonomia International
- Study start
- 23 Jun 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standing | Experimental | Behavioral: StandingParticipants will complete cognitive testing while standing. |
| Supine | Active comparator | Behavioral: SupineParticipants will complete cognitive testing while supine. |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to give, or withdrawal of, informed consent
- Age ≤ 13 or ≥ 61 years
- Prisoners
- Unable to stand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandingParticipants will stand and complete cognitive tests. | Behavioural | Standing |
| SupineParticipants will complete cognitive tests while supine. | Behavioural | Supine |
Primary outcome
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.
3 secondary outcomes
Attention Score Using Cogstate Identification Task
Time frame: 1 hour
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)
Time frame: 1 hour
Heart Rate Standing Minus Heart Rate Supine
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda J Miller, Ph.D. principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing and Supine in people with Postural Tachycardia Syndrome and Ehlers-Danlos Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function (Stroop Word-color Test) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.