SyncopeNCT02167412
EEG Characteristics in Youth POTS and/or Syncope
An observational study of Syncope and Postural Tachycardia Syndrome, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Syncope, Postural Tachycardia Syndrome, Orthostatic Intolerance
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients referred to the neurology-based POTS and Syncope clinic at Nationwide Children's Hospital (Columbus, OH) with POTS or with syncope without POTS and meeting eligibility criteria will be asked to participate.
Who may be able to join
- Patients aged 9-21 years
- Referred to the neurology POTS and Syncope clinic at Nationwide Children's Hospital for clinical tilt table testing
- Has prior diagnosis or signs/symptoms of POTS (with or without syncope) or syncope (without POTS)
Who cannot join
- Cognitive, somatic or psychiatric illness that precludes tilt table testing, prolonged standing, or EEG lead placement
- Known seizure disorder
- Scalp or skull defect that could affect EEG amplitudes
- Pregnancy
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hopsital
Columbus, Ohio, 43205
About this study
Official title: Electroencephalographic (EEG) Characteristics of Postural Tachycardia Syndrome (POTS) and Syncope (Without POTS) During Head-upright Tilt Table Testing
Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. This study will compare EEG characteristics and sweat rate during head-upright tilt (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and lower extremity compression. The primary aim of this study is to characterize video EEG changes that correspond with orthostatic intolerance in youth during HUT testing. The investigators hypothesize that the clinical encephalopathy related to POTS and referred to as 'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2) correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG characteristics that distinguish syncope with POTS from syncope without POTS. The investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to syncope patients without POTS) which are protective of syncope during daily activities.
Read the detailed description
All POTS and syncope patients referred to Nationwide Children's Hospital (Columbus, OH) and meeting study eligibility criteria will be asked to participate. Consent and assent will be obtained per IRB guidelines. Consenting patients will undergo head-upright tilt (HUT) testing with video EEG and continuous sweat monitoring.
Prior to testing all medicines that can affect orthostatic tolerance will be held a minimum of 5 half-lives. Caffeine will be held for a minimum of 24 hours. Urinalysis (for urine specific gravity) and pregnancy testing (for female patients of child-bearing age) will be done the day of HUT testing. A recumbent EEG sample of no less than 10 minutes will be obtained. EKG leads, Holter leads, blood pressure monitors (beat-to-beat and conventional arm cuff), intravenous (IV) line, and sweat monitors will be placed. Sweat rate, EEG, and blood pressure monitoring will be synchronized by event trigger, allowing co-registration of all timed studies during data post-processing. Serum norepinephrine levels will be obtained at the time of IV placement and at 10 minutes of tilt or during/immediately after the syncope prodrome if syncope occurs prior to 10 minutes.
Once all monitors are placed, 10 minutes of EEG have been collected, and the patient has been recumbent for a minimum of 30 minutes, the table is tilted up-right to 70 degrees. A video camera will be on during the test. Patients are encouraged to report all symptoms and they are frequently examined for signs of pallor, acrocyanosis and sweating. Tilt testing is continued until syncope occurs, up to 10 minutes if the patient meets POTS criteria, or up to 45 minutes if neither syncope or POTS is not present.
Those who do meet age-appropriate POTS criteria (symptomatic heart-rate increment >40 bpm or symptomatic total HR of >130 bpm, all within 10 minutes of tilt for those <20 years of age) will be lowered at 10 minutes (or sooner with syncope) and asked to repeat testing with abdominal and lower extremity compression. The compression suit has been used by Dr. Heyer in other NCH studies. It is composed of a Neoprene-like material with 5 Velcro straps that fit snugly around the legs, thighs and abdomen. The abdominal strap contains an air-filled bladder that potentiates abdominal compression. We have used the suit in over 30 consenting patients from prior study. None of the study participants complained of discomfort. The suit successfully reduced both heart rate and orthostatic symptoms in youth with POTS; 55% of studied patients no longer met POTS diagnostic criteria while the suit was on (see PMID: 24840763 for manuscript). We will use the compression suit as our method of attenuating POTS symptoms during HUT testing. EEG will be compared without and with compression.
The time frame for this study is on average 90 minutes. It will not exceed 3 hours. After lowering the tilt table, all monitor leads and the IV will be removed. Once leads are removed there are no further study obligations.
- Keywords
- POTS, Syncope
- Medical subject headings
- Syncope, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Syncope without POTS | Patients meeting syncope criteria without POTS. There will be no intervention for this study arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video EEG characteristics of POTS and syncope
Video EEG characteristics of orthostatic intolerance symptoms related to POTS (with and without syncope) and to syncope (without POTS) will be identified and compared between POTS and syncope cohorts.
Measured: The time frame on average is 90 minutes and will not exceed 3 hours.
Secondary outcomes (3)
EEG characteristics of POTS with and without compression
POTS patients will undergo two separate HUT tests, without and with abdominal and lower extremity compression. EEG characteristics will be compared between trials.
Measured: The time frame on average is 90 minutes and will not exceed 3 hours.
EEG comparison of syncopal prodrome with and without POTS
EEG changes that correspond with the pre-syncopal prodrome (e.g., electrographic slowing) will be compared in terms of duration, quality of onset, and degree of change between syncope patients with and without POTS.
Measured: The time frame on average is 90 minutes and will not exceed 3 hours.
Correlation between sweat rate and EEG changes
Orthostatic intolerance often has associated increases in sweat production. We will compare sweat rate and EEG changes in terms of temporal onset and peak changes to determine if sweat production correlates with EEG slowing.
Measured: The time frame on average is 90 minutes and will not exceed 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Heyer, Nationwide Children's Hospital
- Investigators
- Geoffrey L Heyer, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167412
- Sponsor's protocol ID
- IRB14-00252
- Status last verified
- Mar 2018
- First submitted
- 13 Jun 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic (EEG) Characteristics of Postural Tachycardia Syndrome (POTS) and Syncope (Without POTS) During Head-upright Tilt Table Testing
- ClinicalTrials.gov ID
- NCT02167412
- Acronym / sponsor ID
- IRB14-00252
- Keywords
- POTS, Syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. This study will compare EEG characteristics and sweat rate during head-upright tilt (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and lower extremity compression. The primary aim of this study is to characterize video EEG changes that correspond with orthostatic intolerance in youth during HUT testing. The investigators hypothesize that the clinical encephalopathy related to POTS and referred to as 'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2) correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG characteristics that distinguish syncope with POTS from syncope without POTS. The investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to syncope patients without POTS) which are protective of syncope during daily activities.
Detailed description
All POTS and syncope patients referred to Nationwide Children's Hospital (Columbus, OH) and meeting study eligibility criteria will be asked to participate. Consent and assent will be obtained per IRB guidelines. Consenting patients will undergo head-upright tilt (HUT) testing with video EEG and continuous sweat monitoring.
Prior to testing all medicines that can affect orthostatic tolerance will be held a minimum of 5 half-lives. Caffeine will be held for a minimum of 24 hours. Urinalysis (for urine specific gravity) and pregnancy testing (for female patients of child-bearing age) will be done the day of HUT testing. A recumbent EEG sample of no less than 10 minutes will be obtained. EKG leads, Holter leads, blood pressure monitors (beat-to-beat and conventional arm cuff), intravenous (IV) line, and sweat monitors will be placed. Sweat rate, EEG, and blood pressure monitoring will be synchronized by event trigger, allowing co-registration of all timed studies during data post-processing. Serum norepinephrine levels will be obtained at the time of IV placement and at 10 minutes of tilt or during/immediately after the syncope prodrome if syncope occurs prior to 10 minutes.
Once all monitors are placed, 10 minutes of EEG have been collected, and the patient has been recumbent for a minimum of 30 minutes, the table is tilted up-right to 70 degrees. A video camera will be on during the test. Patients are encouraged to report all symptoms and they are frequently examined for signs of pallor, acrocyanosis and sweating. Tilt testing is continued until syncope occurs, up to 10 minutes if the patient meets POTS criteria, or up to 45 minutes if neither syncope or POTS is not present.
Those who do meet age-appropriate POTS criteria (symptomatic heart-rate increment >40 bpm or symptomatic total HR of >130 bpm, all within 10 minutes of tilt for those <20 years of age) will be lowered at 10 minutes (or sooner with syncope) and asked to repeat testing with abdominal and lower extremity compression. The compression suit has been used by Dr. Heyer in other NCH studies. It is composed of a Neoprene-like material with 5 Velcro straps that fit snugly around the legs, thighs and abdomen. The abdominal strap contains an air-filled bladder that potentiates abdominal compression. We have used the suit in over 30 consenting patients from prior study. None of the study participants complained of discomfort. The suit successfully reduced both heart rate and orthostatic symptoms in youth with POTS; 55% of studied patients no longer met POTS diagnostic criteria while the suit was on (see PMID: 24840763 for manuscript). We will use the compression suit as our method of attenuating POTS symptoms during HUT testing. EEG will be compared without and with compression.
The time frame for this study is on average 90 minutes. It will not exceed 3 hours. After lowering the tilt table, all monitor leads and the IV will be removed. Once leads are removed there are no further study obligations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syncope without POTS | – | –Patients meeting syncope criteria without POTS. There will be no intervention for this study arm. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients referred to the neurology-based POTS and Syncope clinic at Nationwide Children's Hospital (Columbus, OH) with POTS or with syncope without POTS and meeting eligibility criteria will be asked to participate.
Key inclusion criteria (3 listed)
- Patients aged 9-21 years
- Referred to the neurology POTS and Syncope clinic at Nationwide Children's Hospital for clinical tilt table testing
- Has prior diagnosis or signs/symptoms of POTS (with or without syncope) or syncope (without POTS)
Key exclusion criteria (5 listed)
- Cognitive, somatic or psychiatric illness that precludes tilt table testing, prolonged standing, or EEG lead placement
- Known seizure disorder
- Scalp or skull defect that could affect EEG amplitudes
- Pregnancy
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Video EEG characteristics of POTS and syncope
Time frame: The time frame on average is 90 minutes and will not exceed 3 hours.
Video EEG characteristics of orthostatic intolerance symptoms related to POTS (with and without syncope) and to syncope (without POTS) will be identified and compared between POTS and syncope cohorts.
3 secondary outcomes
EEG characteristics of POTS with and without compression
Time frame: The time frame on average is 90 minutes and will not exceed 3 hours.
EEG comparison of syncopal prodrome with and without POTS
Time frame: The time frame on average is 90 minutes and will not exceed 3 hours.
Correlation between sweat rate and EEG changes
Time frame: The time frame on average is 90 minutes and will not exceed 3 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Nationwide Children's Hospital POTS and Syncope clinicLink provided by the sponsor.
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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.
Geoffrey L Heyer, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Postural Tachycardia Syndrome, run by Nationwide Children's Hospital 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 3 inclusion and 5 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 27 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Video EEG characteristics of POTS and syncope (time frame: The time frame on average is 90 minutes and will not exceed 3 hours.). 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 27 Mar 2018.