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Compression Garments
Compression Garments for POTS (COM-COM-POTS Trial)
N/A
Recruiting
Led By Satish M Raj, MD MSCI
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physician diagnosis of Postural Tachycardia Syndrome (POTS)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes
Awards & highlights
COM-COM-POTS Trial Summary
This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.
Who is the study for?
This trial is for adults in Canada with a doctor's diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS) who can participate in a 4-day study and own waist-high compression tights. It excludes those with conditions that mimic POTS, severe anxiety, pregnancy, intolerance to compression garments, or non-ownership of the required garment.Check my eligibility
What is being tested?
The trial tests if wearing commercially available waist-high and abdominal compression garments helps manage heart rate and symptoms in POTS patients outside the lab. Participants will use these garments during their daily activities over two segments separated by five days without them.See study design
What are the potential side effects?
Potential side effects from using compression garments may include discomfort, skin irritation or marks, dizziness upon removal due to blood pressure changes, and possible worsening of symptoms if not used correctly.
COM-COM-POTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with POTS by a doctor.
COM-COM-POTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AC Heart Rate
WHC Heart Rate
Secondary outcome measures
Heart Rate - AC and Medication
Heart Rate - End of Study Day (AC)
Heart Rate - End of Study Day (WHC)
+2 moreCOM-COM-POTS Trial Design
4Treatment groups
Experimental Treatment
Group I: Waist-High Compression Tights and No MedicationsExperimental Treatment1 Intervention
Participants will wear the waist-high compression garment while holding their regular medications that modulate heart rate and blood pressure (beta-blockers, midodrine, ivabradine, stimulants). This arm will look at the effectiveness of waist-high compression without medications. This arm will also include control measurements before the garment is put on and after the garment is removed.
Group II: Waist-High Compression Tights and MedicationsExperimental Treatment2 Interventions
Participants will wear the waist-high compression garment while taking their regularly prescribed medications. This arm will evaluate the effects of waist-high compression garment treatment together with medications that modulate heart rate and blood pressure. This arm will also include control measurements before the garment is put on and after the garment is removed.
Group III: Abdominal Compression Garments and No MedicationsExperimental Treatment1 Intervention
Participants will wear the abdominal compression garment while holding their regular medications that modulate heart rate and blood pressure (beta-blockers, midodrine, ivabradine, stimulants). This arm will look at the effectiveness of abdominal compression without medications. This arm will also include control measurements before the garment is put on and after the garment is removed.
Group IV: Abdominal Compression Garments and MedicationsExperimental Treatment2 Interventions
Participants will wear the abdominal compression garment while taking their regularly prescribed medications. This arm will evaluate the effects of abdominal compression garment treatment together with medications that modulate heart rate and blood pressure. This arm will also include control measurements before the garment is put on and after the garment is removed.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,124 Total Patients Enrolled
8 Trials studying Postural Orthostatic Tachycardia Syndrome
583 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Satish M Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with POTS by a doctor.You will be excluded if you have severe anxiety or somatization symptoms.I can commit to a 4-day study with a break in between.You cannot wear tight clothing for the entire study.You have a compression garment for your abdomen.I own medical or commercial compression tights with a specified pressure rating.I do not have conditions like dehydration or thyroid disease causing my fast heartbeat when standing.
Research Study Groups:
This trial has the following groups:- Group 1: Abdominal Compression Garments and Medications
- Group 2: Abdominal Compression Garments and No Medications
- Group 3: Waist-High Compression Tights and Medications
- Group 4: Waist-High Compression Tights and No Medications
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary goals of this medical experiment?
"This 10-minute trial seeks to ascertain the effect of Heart Rate on Adrenergic Catecholamine (AC) levels. Secondary objectives include measuring variations in HR between With and Without Medication phases, WHC Day compared to AC day when accounting for Drug Administration, and differences in Delta HR from OVS #3 (with AC) observed against OVS #4 (without)."
Answered by AI
Might I be eligible to enroll in this experiment?
"Eligible applicants for this experiment should have a diagnosis of postural orthostatic tachycardia syndrome, be aged 18-60, and must make up the total number of 30 participants."
Answered by AI
Are any participants being recruited for this research endeavor?
"According to the clinicaltrials.gov listing, this investigation is currently enlisting patients. The post first went live on May 17th 2021 and was updated as recently as February 7th 2022."
Answered by AI
Is there an age restriction to join this study?
"Participants must be between 18 and 60 years old to join this trial. Alternatively, 15 trials are available for minors while 97 studies are catered towards individuals over 65."
Answered by AI
How many research subjects are involved in the experiment?
"Yes, indeed. Per the clinicaltrials.gov website, this research initiative is currently recruiting participants; it was first posted on May 17th 2021 and last updated on February 7th 2022. Across one site, 30 patients are necessary for enrollment in this trial."
Answered by AI
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