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Breathing Device for POTS
N/A
Waitlist Available
Led By Satish R Raj, MD MSCI
Research Sponsored by Alfredo Gamboa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 min
Awards & highlights
Study Summary
This trial will test whether a breathing device can help people with postural tachycardia syndrome stay upright and reduce heart rate increases when standing.
Who is the study for?
This trial is for individuals diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center, who experience a heart rate increase of at least 30 beats/min when standing up and have symptoms that improve when lying down. Participants must be able to consent. Pregnant individuals or those unable to complete the study are excluded.Check my eligibility
What is being tested?
The study is examining if using an Inspiratory Threshold Device (Res-Q-Gard ITD), which adds resistance to breathing, can help POTS patients stand upright more comfortably and reduce rapid heartbeat upon standing. A sham device serves as a comparison in this experiment.See study design
What are the potential side effects?
Potential side effects may include discomfort from using the breathing device, possible lightheadedness or shortness of breath due to increased effort during inhalation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms, like dizziness, improve when I lie down.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 min
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 min
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnitude of orthostatic heart rate increase on upright posture
Secondary outcome measures
Hemodynamic changes on upright posture
Symptoms rating with upright posture
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ITD breathing deviceExperimental Treatment1 Intervention
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
Group II: Sham DevicePlacebo Group1 Intervention
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
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Who is running the clinical trial?
Alfredo GamboaLead Sponsor
1 Previous Clinical Trials
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
672,162 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
879 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Satish R Raj, MD MSCIPrincipal InvestigatorVanderbilt University School of Medicine
19 Previous Clinical Trials
1,396 Total Patients Enrolled
7 Trials studying Postural Orthostatic Tachycardia Syndrome
577 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My symptoms, like dizziness, improve when I lie down.You have been diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center.Your heart rate goes up by 30 beats per minute or more when you stand up from lying down.I have a rapid heartbeat when standing up due to a clear reason like dehydration.
Research Study Groups:
This trial has the following groups:- Group 1: ITD breathing device
- Group 2: Sham Device
Awards:
This trial has 0 awards, including: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.
Is there still capacity in this experiment for more participants?
"According to clinicaltrials.gov, this particular medical study, originally posted on October 1st 2009 and last modified November 22nd 2022, is not currently enrolling patients. Nevertheless, 1484 other trials are actively registering volunteers."
Answered by AI
Does this investigation include participants of greater than 35 years old?
"According to the trial's admission criteria, any patient aged between 18 and 80 can be accepted. Statistically speaking, there are 387 trials for minors under 18 years-old and 1071 studies targeting elderly people above 65."
Answered by AI
Would I be able to participate in this medical research?
"This investigation is in search of 30 individuals with postural orthostatic tachycardia syndrome, within the age range 18-80. Critically, applicants must be able to demonstrate an increase in heart rate of at least 30 beats per minute (bpm) when switching from a supine position to standing up over 10 minutes."
Answered by AI
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