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Not yet recruiting NCT05618067

The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

No phase Interventional Postural Tachycardia Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: breathing exercise training.
Who it may be relevant to
Registry conditions: Postural Tachycardia Syndrome. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Change in periaqueductal gray region (PAG) activation - looming task [Time frame: 90 minutes]
  • Change in PAG activation - resting [Time frame: 90 minutes]
  • Change in Heart Rate Variability (HRV) [Time frame: Assessed for 2 days each week for the duration of the study (6 weeks).]
Secondary outcome measures (10)
  • Change in Fatigue Severity Scale (FSS) score from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Differences in Adverse Childhood Experiences (ACE) scores between participants [Time frame: Assessed at baseline.]
  • Change in Pain Catastrophizing Scale (PCS) score from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in Patient Health Questionnaire (PHQ-9) score from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in Pittsburgh Sleep Quality Index (PSQI) from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in PROMIS Physical Function (PROMIS 8b) from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in the Perceived Stress Scale (PSS) from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in the PTSD Checklist (PCL-5) from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]
  • Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline [Time frame: Assessed at baseline, week 3, and week 6 (final visit).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Virnigia Commonwealth University — Richmond

Identifiers

NCT: NCT05618067 · HM20025315

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗