The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

NCT ID: NCT05618067

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.

Conditions

Postural Tachycardia Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Training

Group Type: EXPERIMENTAL

breathing exercise training

Intervention Type: BEHAVIORAL

Participants will engage in weekly breathing exercises. They will be trained once a week for 4 weeks, and will use an app called Inner Balance and an device called Firstbeat Bodyguard 3 to track data about their hearts while practicing the exercises at home for 10 minutes a day, twice a day, once before bedtime.

Interventions

breathing exercise training

Participants will engage in weekly breathing exercises. They will be trained once a week for 4 weeks, and will use an app called Inner Balance and an device called Firstbeat Bodyguard 3 to track data about their hearts while practicing the exercises at home for 10 minutes a day, twice a day, once before bedtime.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-50 years
• Diagnosis of POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
• Can speak and read in English
• Upcoming new patient VCU Comprehensive Autonomics Center clinic visit scheduled at least 1 week in the future

Exclusion Criteria

• Inflammatory arthritis, connective tissue or auto-immune disorder
• Any chronic neurological disorder besides POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
• Patients who have already had a new patient clinic visit where they were exposed to breathing exercise education
• Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
• Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
• Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
• Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
• Current substance or alcohol abuse
• Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
• Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
• Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
• Chronic use of narcotics for pain
• Claustrophobia or any metal hardware that may interfere with MRI
• Investigators and study staff

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Chelimsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virnigia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Central Contacts

Thomas Chelimsky, M.D.

Role: CONTACT

thomas.chelimsky@vcuhealth.org

(804)-628-0145

Madison Maxwell, B.S.

Role: CONTACT

maxwellme@vcu.edu

Other Identifiers

HM20025315

Identifier Type: -

Identifier Source: org_study_id