Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog

Официальное название

Pilot Study to Investigate Possible Non-invasive Treatment for Long COVID (Post COVID-19 Condition) Brain Fog

Обзор

This study aims to assess the effects of both acute and chronic exposures to hypoxia and hypercapnia in patients with Long COVID syndrome.

Вмешательства

• Другое Acute Placebo Visit
  The placebo visit will include 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air.
• Другое Acute Progressive Carbon Dioxide
  The progressive carbon dioxide visit will include a 60-minute progressive ramp which includes 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles.
• Другое Acute Intermittent Hypoxia
  The intermittent hypoxia exposure visit will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air.
• Другое Training: Progressive Carbon Dioxide Ramping
  Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the progressive CO2 ramp protocol of 60-minute sessions, which will include 6 cycles of progressive CO2 ramping starting at 0% and progressing up to 10% within 5 minutes immediately followed with 5 minutes of room air breathing in between cycles, for every visit during the 14 days.
• Другое Training: Intermittent Hypoxic Exposure
  Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will will be given the intermittent hypoxia exposure protocol of 60-minute sessions, which will include 6 cycles breathing 8-12% oxygen (O2) for 5 minutes with a target pulse oximeter saturation of 86-90%, followed by 5 minutes of breathing room air for every visit during the 14 days.
• Другое Training: Placebo Control
  Intervention will consist of 6 to 10 study visits (3-5 sessions/week) to be completed within 14 days. Subjects will complete 6 simulated cycles of 5 minutes breathing 21% oxygen from a douglas bag and 5 minutes breathing room air (60 minutes) for every visit during the 14 days.

Первичные конечные точки

• Change in cerebral blood flow [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in heart rate variability [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in brain fog scale [Срок оценки: Baseline, post-acute exposure and 14 days post training]

Вторичные конечные точки (6)

• Change in fatigue functional assessment of chronic illness therapy-fatigue scale [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in short form health survey (SF-36) [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in Trail making test [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in rapid cognitive assessment tool (RCAT) score [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in Task switching test performance [Срок оценки: Baseline, post-acute exposure and 14 days post training]
• Change in Rey Auditory Verbal Learning Test (AVLT) recall [Срок оценки: Baseline, post-acute exposure and 14 days post training]

Критерии участия

Критерии включения

• English speaking
• Diagnosis of Long COVID

Критерии исключения

• Any history of:

• Coronary artery dissection or aortic dissection
• Neurological disease (e.g. dementia, Alzheimer's disease, or other brain-related disease)
• Cerebrovascular disease or stroke
• Aneurysm
• If currently has:

• Moderate-severe chronic obstructive pulmonary disease
• Uncontrolled moderate-severe asthma
• Moderate-severe bronchiectasis
• Moderate-severe interstitial lung disease, requiring the use of supplemental oxygen
• A necessity to use supplemental oxygen, for any reason
• New or worsening symptoms (decompensation) of heart failure
• Right heart disease due to chronic pulmonary disease/sleep apnea
• Uncontrolled myocardial ischemia or angina
• Uncontrolled heart arrhythmias
• Heart or lung infection (e.g. myocarditis or pericarditis)
• Left main coronary artery stenosis
• Moderate-severe aortic stenosis
• Pulmonary embolism, pulmonary infarction, or other blood clots
• Severe respiratory disease
• Chronic kidney disease
• Chronic liver disease
• Females of childbearing potential will complete a urine pregnancy test at their baseline visit to rule out pregnancy
• BMI >40
• Study staff unable to obtain adequate signal for cerebral blood flow

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Arizona — Scottsdale

Идентификаторы

NCT: NCT06614309 · 24-006115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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