Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

Study Overview
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Brief Summary
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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.

Official Title
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Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

Conditions
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Postural Orthostatic Tachycardia Syndrome (POTS), Syncope

Intervention / Treatment
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* Device: Zoex compression garment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-19 years POTS diagnosis English speaking - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal and LE compression<br>Zoex compression garment during tilt testing (all straps) | Device: Zoex compression garment<br>* 5-strap compression of abdomen, thighs and legs<br>|
| Experimental: abdominal compression only<br>Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen) | Device: Zoex compression garment<br>* 5-strap compression of abdomen, thighs and legs<br>|
| Experimental: Lower extremity compression only<br>Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened) | Device: Zoex compression garment<br>* 5-strap compression of abdomen, thighs and legs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart-rate elevation |  | Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom onset |  | Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POTS, Orthostatic, Adolescent