Status:
COMPLETED
Effects of Cold Exposure and Breathing Techniques on Immune Response
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Cold Exposure
Hyperventilation
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative non-pharmacological therapies aimed at limiting cytokine production are highly warranted. Recently, our group sho...
Detailed Description
Auto-immune diseases are characterized by an inappropriate inflammatory response against tissues in the body. These diseases, of which rheumatoid arthritis (RA) is the most well-known, represent a maj...
Eligibility Criteria
Inclusion
- Written informed consent
- Male
- Healthy
Exclusion
- Prior experience with any of the elements of the intervention developed by Hof
- Prior experience with other breathing, meditation, or cold exposure techniques
- Prior experience with mindfulness or yoga
- Prior experience with exposure to cold showers
- Frequent visits to sauna facilities (more than 1/month)
- Use of any medication
- Smoking
- History of asthma
- History of porphyria
- Previous spontaneous vagal collapse
- History of atrial or ventricular arrhythmia
- (Family) history of myocardial infarction or stroke under the age of 65 years
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
- Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90)
- Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50)
- Renal impairment (defined as plasma creatinin \>120 μmol/l)
- Liver enzyme abnormalities
- Medical history of any disease associated with immune deficiency
- CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within
- 4 weeks before endotoxin administration
- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge
- Use of recreational drugs within 7 days prior to endotoxemia experiment day
- Recent hospital admission or surgery with general anaesthesia (\<3 months)
Key Trial Info
Start Date :
April 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03240497
Start Date
April 12 2016
End Date
April 1 2018
Last Update
April 1 2019
Active Locations (1)
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1
Radboud University Medical Centre, Intensive Care
Nijmegen, Netherlands, 6525 GA