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Набор скоро начнётся NCT05618067

The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

Без фазы С лечением Postural Tachycardia Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: breathing exercise training.
Кому может быть актуально
Состояния в реестре: Postural Tachycardia Syndrome. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Virnigia Commonwealth University — Richmond

Идентификаторы

NCT: NCT05618067 · HM20025315

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗