30 Participants Needed

Compression Garments for POTS

(COM-COM-POTS Trial)

KM
Overseen ByKate M Bourne, BSc
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.

Research Team

SM

Satish M Raj, MD MSCI

Principal Investigator

University of Calgary

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with POTS by a doctor.
Resident of Canada
I can commit to a 4-day study with a break in between.
See 2 more

Exclusion Criteria

You will be excluded if you have severe anxiety or somatization symptoms.
Not a resident of Canada
You cannot wear tight clothing for the entire study.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants will wear compression garments and undergo standing tests with and without medications

4 days
Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Compression Garments
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security