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Saline Infusion for Chronic Fatigue Syndrome

N/A
Recruiting
Led By Benjamin Natelson, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet the 2015 IOM case definition for ME/CFS
Ages 25 to 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days
Awards & highlights

Study Summary

This trial is testing whether people with Chronic Fatigue Syndrome have different cardiopulmonary function than the general population, and if so, whether this could be the cause of the symptom Post-exertional malaise.

Who is the study for?
This trial is for individuals aged 25 to 60 who have been diagnosed with Chronic Fatigue Syndrome (CFS) and experience Post-exertional malaise (PEM). It's not open to those with medical reasons for fatigue, on heart-affecting meds, or with recent histories of major psychiatric disorders, eating disorders, or substance abuse.Check my eligibility
What is being tested?
The study aims to understand cardiopulmonary function in CFS patients by having them do maximal exercise tests on two consecutive days. Some will receive a saline infusion before the second test if they show low blood volume initially. The goal is to see if this affects their PEM symptom.See study design
What are the potential side effects?
Since the intervention involves saline infusion which is generally safe and commonly used in medical settings, side effects are minimal but may include discomfort at the injection site or rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ME/CFS according to the 2015 IOM criteria.
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I am between 25 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CPET testing
Hypovolemia
Total Blood Volume

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Saline InfusionExperimental Treatment1 Intervention
Group II: Sham InfusionPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline Infusion
2008
N/A
~30

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,342 Previous Clinical Trials
650,305 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
863 Previous Clinical Trials
525,567 Total Patients Enrolled
Benjamin Natelson, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Saline Infusion Clinical Trial Eligibility Overview. Trial Name: NCT04740736 — N/A
Chronic Fatigue Syndrome Research Study Groups: Saline Infusion, Sham Infusion
Chronic Fatigue Syndrome Clinical Trial 2023: Saline Infusion Highlights & Side Effects. Trial Name: NCT04740736 — N/A
Saline Infusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740736 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are being monitored for this clinical investigation?

"Affirmative. Data housed on clinicaltrials.gov attests that this study is looking for participants, having first been posted on August 31st 2021 and lastly edited on November 23rd 2022. 80 individuals need to be enrolled at just a single site."

Answered by AI

Are there any vacancies for individuals to participate in this experiment?

"According to clinicaltrials.gov, this trial is open for recruitment and has been since August 31st 2021. The most recent update was made on November 23rd 2022."

Answered by AI

Do you accept participants below 30 years of age for this trial?

"To qualify for this trial, potential participants must be between 25 and 60 years of age."

Answered by AI

Is there an opportunity to participate in this research endeavor?

"This research project is enrolling 80 adults between the ages of 25 and 60 who have been diagnosed with Chronic fatigue syndrome (CFS). Furthermore, those enrolled must satisfy all criteria outlined by the 2015 Institute of Medicine case definition for ME/CFS."

Answered by AI

Who else is applying?

What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Cardiovascular Analysis of PEM
Benjamin Natelson 2021. "Cardiovascular Analysis of PEM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04740736.
All > Me Cfs > Chronic Fatigue Syndrome
~10 spots leftby Feb 2025
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