Hyperbaric Oxygen Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - A Prospective, Randomized, Double-Blind, Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Cardiopulmonary exercise test (CPET)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
Sham Hyperbaric oxygen therapy
SHAM therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.02 ATA for 90 minutes with 5-minute air breaks, every 20 minutes.
干预措施: SHAM treatment (Device)
Hyperbaric oxygen therapy
Hyperbaric Oxygen Therapy: 60 consecutive sessions, 5 sessions per week within a three months' period. Each session includes breathing 100% oxygen by mask at 2 ATA for 90 minutes with 5-minute air breaks every 20 minutes.
干预措施: Hyperbaric oxygen therapy (Device)
结局指标
主要结局
Cardiopulmonary exercise test (CPET)
时间窗: 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
Physical performance evaluated by cardiopulmonary exercise test (CPET) on a bicycle or a treadmill. CPET will be used to determine the peak oxygen consumption (Peak VO2), first ventilatory threshold (VT1) and if possible, the second ventilatory threshold (VT2). The day after each CPET an FUNCAP55 questionnaire will be filled to assess the functional capacity.
次要结局
- FUNCAP55 - a 55-item functional capacity questionnaire(The day after each CPET. and once a month during the study)
- Urine Test(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)
研究者
Eli Kravchik
Principal Investigator, MD
Assaf-Harofeh Medical Center