Postural Orthostatic Tachycardia Syndrome (POTS)NCT01795469
Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
A study testing Zoex compression garment in people with Postural Orthostatic Tachycardia Syndrome (POTS) and Syncope, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS), Syncope
- What is being tested?
- Zoex compression garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2016
- Phase
- Interventional
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-19 years
- POTS diagnosis
- English speaking -
Who cannot join
- Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing
- Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital, neurology outpatient clinic
Columbus, Ohio, 43205
About this study
Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.
- Being tested
- Zoex compression garment
- Keywords
- POTS, Orthostatic, Adolescent
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoex compression garmentDevice
5-strap compression of abdomen, thighs and legs
| Study group | Role | What they receive |
|---|---|---|
| Abdominal and LE compression | Experimental | Zoex compression garment during tilt testing (all straps) Receives: Device: Zoex compression garment |
| abdominal compression only | Experimental | Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen) Receives: Device: Zoex compression garment |
| Lower extremity compression only | Experimental | Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened) Receives: Device: Zoex compression garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-rate elevation
Measured: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression
Secondary outcomes (1)
Symptom onset
Measured: Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795469
- Sponsor's protocol ID
- IRB13-00033 (NCH IRB number)
- Status last verified
- Jan 2017
- First submitted
- 18 Feb 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heyer GL. Abdominal and lower-extremity compression decreases symptoms of postural tachycardia syndrome in youth during tilt table testing. J Pediatr. 2014 Aug;165(2):395-7. doi: 10.1016/j.jpeds.2014.04.014. Epub 2014 May 17.
PubMed 24840763
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
- ClinicalTrials.gov ID
- NCT01795469
- Acronym / sponsor ID
- IRB13-00033 (NCH IRB number)
- Keywords
- POTS, Orthostatic, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Feb 2013 (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.
Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abdominal and LE compression | Experimental | Device: Zoex compression garmentZoex compression garment during tilt testing (all straps) |
| abdominal compression only | Experimental | Device: Zoex compression garmentZoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen) |
| Lower extremity compression only | Experimental | Device: Zoex compression garmentZoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened) |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 12-19 years
- POTS diagnosis
- English speaking -
Key exclusion criteria (2 listed)
- Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing
- Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -
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 |
|---|---|---|
| Zoex compression garment5-strap compression of abdomen, thighs and legs | Device | Abdominal and LE compression, Lower extremity compression only, abdominal compression only |
Primary outcome
Heart-rate elevation
Time frame: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression
1 secondary outcome
Symptom onset
Time frame: Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression
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 31 Jan 2017.
- Results publication: PubMed 24840763Heyer GL. Abdominal and lower-extremity compression decreases symptoms of postural tachycardia syndrome in youth during tilt table testing. J Pediatr. 2014 Aug;165(2):395-7. doi: 10.1016/j.jpeds.2014.04.014. Epub 2014 May 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoex compression garment in people with Postural Orthostatic Tachycardia Syndrome (POTS) and Syncope, 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 2 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 31 Jan 2017. 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?
Heart-rate elevation (time frame: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795469, which also lists 1 linked publication.
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 31 Jan 2017.