Effectiveness of a 3-months Dietary Supplementation Based on Quercetin Phytosome®) for the Treatment of Chronic Fatigue Syndrome
The purpose of this study is to evaluate whether a 3-month period of quercetin supplementation (500 mg of Quercetin Phytosome®) is useful in the treatment of chronic fatigue, as assessed by the Fatigue Impact Scale (FIS-40). Secondary end points are sleep assessment through Pittsburgh Sleep Quality Index (PSQI) and muscle performance assessment through the Short Physical Performance Battery (SPPB) and body composition assessment using DXA.
NCT05730660 — Sleep
Status: Completed
http://inclinicaltrials.com/sleep/NCT05730660/
Double-blinded, Randomized, Sham-controlled Trial of Immunoadsorption (IA) in Patients With Chronic Fatigue Syndrome (CFS) Including Patients With Post-acute COVID-19 CFS (PACS-CFS)
The goal of this clinical trial is to learn about the effectiveness of repeated immunoadsorption intervention in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS). The main questions it aims to answer are: (1) Does repeated immunoadsorption relieve fatigue and/or other symptoms associated with CFS and PACS-CFS? (2) Is repeated immunoadsorption safe and tolerable in this patient population? What are the side effects of repeated immunoadsorption, and how common are they? Participants will be asked to participate for approx. 32 weeks (8 months). After screening, participants will receive assigned intervention of either five immunoadsorption treatments (with Ig adsorber) every other day over 10 days or matching sham treatments (without Ig adsorber), followed by a 6-month follow-up period with three ambulatory visits. Every participant will undergo trial outcome, safety, and monitoring assessments. The results of this study will provide information on whether repeated immunoadsorption can alleviate symptoms associated with CFS and PACS-CFS, as well as insights into the pathophysiological processes in this condition, which in turn can help to develop new and effective therapies.
NCT05710770 — ME/CFS
Status: Recruiting
http://inclinicaltrials.com/me-cfs/NCT05710770/
Post-COVID-19 Chronic Fatigue Syndrome
Fatigue is recognized as one of the most commonly presented long-term complaints in individuals previously infected with SARS-CoV-2.
NCT05642923 — Post-COVID-19 Syndrome
Status: Recruiting
http://inclinicaltrials.com/post-covid-19-syndrome/NCT05642923/
Effect of Intensive Combined Rehabilitation Therapy for Patients With Post COVID 19 Chronic Fatigue Syndrome
The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .
NCT05534997 — Post-COVID-19 Syndrome
Status: Not yet recruiting
http://inclinicaltrials.com/post-covid-19-syndrome/NCT05534997/
Effect of Melatonin Plus Zinc Supplementation on Fatigue, Pain, Sleep Disturbances, Anxiety and Depression, and Autonomic Dysfunction in ME/CFS: a Randomized, Double-blind, Placebo-controlled Study
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
NCT05454683 — Chronic Fatigue Syndrome
Status: Recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT05454683/
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome
The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.
NCT05397626 — Chronic Fatigue Syndrome
Status: Recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT05397626/
Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.
The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.
NCT05323838 — Fibromyalgia
Status: Active, not recruiting
http://inclinicaltrials.com/fibromyalgia/NCT05323838/
Inspiratory Muscle Training in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and COVID-19 Survivors
Coronavirus-2019 (COVID-19) is a viral disease leading to respiratory dysfunction, but it may also affect the brain and result in the development of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This may be the result of the COVID-19 virus infecting regions of the brain responsible for respiratory control. The symptoms of COVID-19 long haulers and ME/CFS may be lessened via an 8-week inspiratory muscle training protocol which is a simple and easy training protocol which can be done at a patient's home. Thus, this project will investigate changes in the breathing and cardiovascular responses to stimuli in three groups of participants: 1) healthy control individuals; 2) patients diagnosed with ME/CFS (mild to moderate symptoms); and 3) individuals with previous COVID-19 infection with long-haul symptoms lasting for at least 3 months. Participants will 1) breathe hypoxic gas (10% O2) for 5 minutes; 2) breath hypercapnic gas (5% CO2) for 5 minutes; 3) breathe at a rate of 6 breaths per minute for a total of 8 breaths (paced deep breathing); and 4) complete 10 minutes upright tilt (70 degrees head up on a tilt-table). Patients will also complete 2 questionnaires concerning their symptoms and a 15 minute cognitive function test on a lab laptop. This will allow for the assessment of the brain's control over blood pressure and breathing. Participants will also complete a 6-minute walking exercise test at their own speed as a measure of their aerobic fitness. We hypothesize that COVID-19 survivors will have a worse cardiovascular and autonomic response and lower fitness, similar to ME/CFS patients, compared to healthy participants.Further, this will be improved after 8-weeks of inspiratory muscle training. These results may help clinicians recognize ME/CFS symptoms in patients recovering from COVID-19.
NCT05196529 — Post-acute COVID-19 Syndrome
Status: Completed
http://inclinicaltrials.com/post-acute-covid-19-syndrome/NCT05196529/
Study to Determine the Effectiveness of Therapy Methods (Acceptance Commitment Therapy, Micro Breaks) in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria. Diagnosis requires that the patient have the following three symptoms: 1. A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, 2. Post-exertional malaise,* and 3. Unrefreshing sleep* At least one of the two following manifestations is also required: 1. Cognitive impairment* or 2. Orthostatic intolerance Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity. Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work. The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy. The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
NCT05168124 — Fatigue Syndrome, Chronic
Status: Recruiting
http://inclinicaltrials.com/fatigue-syndrome-chronic/NCT05168124/
Hydrogen Water as a Treatment for Chronic Fatigue Syndrome: A Pilot Study
The proposed placebo-controlled pilot study will examine hydrogen water as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). 25 subjects who meet strict criteria for ME/CFS will be recruited. The 30 day trial will involve subjects ingesting 1-5 8 oz. glasses of hydrogen-dissolved water per day. The placebo condition will involve the same daily ingestion schedule but with an inert placebo pill instead of the active hydrogen treatment pill. The proposed study is intended to establish feasibility of the clinical protocol and examine potential treatment effects of hydrogen water which may include symptom reduction and possibly improved functioning. If feasibility and apparent treatment effects are confirmed, a large clinical trial will be proposed for submission to NIH. In addition to potential therapeutic properties, H2 water is portable, easily administered and safe to ingest. Self-report assessments for ME/CFS symptoms, fatigue, autonomic symptoms, physical function, anxiety, and depression will be done in the week before and the week after the 30 day trial. In addition, 7-day home-based objective assessments of heart rate variability (a measure of parasympathetic function) and accelerometry (a physical activity assessment) will be scheduled before and after the intervention period.
NCT05013606 — Chronic Fatigue Syndrome
Status: Completed
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT05013606/