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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01795469
Other study ID # IRB13-00033 (NCH IRB number)
Secondary ID
Status Completed
Phase N/A
First received February 18, 2013
Last updated January 28, 2017
Start date February 2013
Est. completion date February 2016

Study information

Verified date January 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 12 Years to 19 Years
Eligibility Inclusion Criteria:

1. Age 12-19 years

2. POTS diagnosis

3. English speaking -

Exclusion Criteria:

1. Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing

2. Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -

Study Design


Related Conditions & MeSH terms

  • Postural Orthostatic Tachycardia Syndrome
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Syncope
  • Tachycardia

Intervention

Device:
Zoex compression garment
5-strap compression of abdomen, thighs and legs

Locations

Country Name City State
United States Nationwide Children's Hospital, neurology outpatient clinic Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Heart-rate elevation Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression
Secondary Symptom onset Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression
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