Набор скоро начнётся NCT07621068
Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS)
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: Hyperbaric oxygen therapy, SHAM treatment.
- Кому может быть актуально
- Состояния в реестре: Chronic Fatigue Syndrome. Базовые параметры: от 18 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
- Израиль
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Hyperbaric Oxygen Therapy for Chronic Fatigue Syndrome (CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study
Обзор
This study evaluates the effects of hyperbaric oxygen therapy (HBOT) in patients with mild to moderate CFS/ME. Participants will undergo 60 HBOT sessions over 3 months with a 3-month follow-up, including physical, cognitive, imaging, and laboratory assessments.
Подробное описание
Hyperbaric oxygen therapy (HBOT) for Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) - The aim of the current study is to evaluate the effect of HBOT on patients suffering for mild to moderate CFS. Patients will undergo a series of 60 HBOT over a span of 3 months, with a 3 month follow-up period. Patient's evaluation point includes the following tests: physical performance, questionnaires, cognitive tests, brain MRI, EEG, blood tests \& muscle biopsy.
Вмешательства
- Устройство Hyperbaric oxygen therapy
60 consecutive sessions of breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period. - Устройство SHAM treatment
60 consecutive sessions of breathing 21% oxygen by mask at 1 ATA for 90 minutes with 5-minute air breaks every 20 minutes, 5 sessions per week within a three months' period.
Первичные конечные точки
- Cardiopulmonary exercise test (CPET) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
Вторичные конечные точки (12)
- DePaul Post-Exertional Malaise Questionnaire (DPEMQ) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Short Form-36 Health Survey (SF-36) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Brief Symptom Inventory-18 (BSI-18) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- NeuroTrax [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Brain MRI [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Brain EEG [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Sleep EEG [Срок оценки: Baseline (3 consecutive nights within 2 weeks before treatment), post-treatment (3 consecutive nights within 21±7 days after last HBOT/Sham session), and at the end of the 3-month follow-up period (3 consecutive nights)]
- Orthostatic Intolerance - 10-min NASA Lean Test (NLT) [Срок оценки: Baseline, monthly during treatment (3 months), at the post-treatment evaluation (within 21±7 days after last HBOT/Sham session), monthly during follow-up (3 months), at the end of the follow-up period (end of study evaluation).]
- Body Composition [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
- Hand Grip test [Срок оценки: Baseline, post treatment evaluation within 21±7 days of last HBOT/Sham session, End of study evaluation: at the end of 3 month follow-up period]
Критерии участия
Критерии включения
- Subject willing and able to read, understand and sign an informed consent
- Diagnosis of mild to moderate severity of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Patients diagnosed with CFS for more than 1 years
- Stable psychological and pharmacological treatment for more than three months prior to inclusion
Критерии исключения
- Inability to attend scheduled clinic visits and/or comply with the study protocol
- Severe and very severe cases of ME/CFS
- History or diagnosis of, brain tumors, brain surgery, epilepsy, neurodegenerative diseases
- Active malignancy
- Substance use at baseline, except for prescribed cannabis if vaporized or taken PO as tincture
- Active smokers
- Chronic heart failure with ejection fraction of 30 or less
- Chest pathology incompatible with pressure changes (including active asthma or COPD)
- Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)
- Pregnancy
- An inability to perform an awake brain MRI
- An inability to perform Neurotrax
- Participation in another medical study
- HBOT for any reason prior to study enrolment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Израиль · 1 центр
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Идентификаторы
NCT: NCT07621068 · 0015-26-ASF