Mild Water-filtered Infrared-A Whole-body Hyperthermia in Patients With Post-COVID Syndrome (HyPoCo)

NCT06204458 | Active Not Recruiting

• 1 other identifier: 23050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the efficacy of mild water-filtered whole-body hyperthermia during outpatient treatment in patients with post-COVID syndrome. The aim is to evaluate whether there can be an improvement in fatigue and quality of life. The duration of the study extends over a treatment period of approximately 2 weeks with two treatment units per week and a follow-up period of 3 months after the outpatient treatment.

Conditions

Post-COVID Syndrome

Keywords

hyperthermia; fatigue; post-COVID syndrome

Outcome Measures

Primary Outcomes (2)

• Multidimensionl Fatigue Inventory (MFI-20)

  An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).

  Week 0

• Multidimensionl Fatigue Inventory (MFI-20)

  An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue).

  Week 3

Secondary Outcomes (27)

• Multidimensionl Fatigue Inventory (MFI-20)

  Week 15

• Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)

  Week 0

• Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)

  Week 3

• Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)

  Week 15

• Pittsburgh Sleep quality index (PSQI)

  Week 0

Other Outcomes (19)

• Blood count

  Week 0

• Blood count

  Week 2

• Blood count

  Week 3

Study Arms (2)

mild hyperthermia group

EXPERIMENTAL

For the study, the method of passive whole-body hyperthermia is used. The IRATHERM®1000 system (Von Ardenne Institute for Applied Medical Research/Dresden) is used, in which the entire body is heated to a core body temperature above the physiological 37°C under the application of 10L/min oxygen. The aim is to achieve a core body temperature of 38.5°C within the framework of mild whole-body hyperthermia. After this warm-up phase, a temperature plateau phase of about 60 minutes follows, in which an attempt is made to maintain the core body temperature of 38.5°C. In the temperature plateau phase, a slight increase in the body core temperature is usually observed. The total time required for a session is given as 1.5 to 2 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations.

Other: mild hyperthermia group

sham group

SHAM COMPARATOR

Within the patient information, privacy policy, etc., there is talk of "gentle hyperthermia" and classic, "mild hyperthermia". This serves to introduce the sham intervention as a control group compared to the patient. Lighting conditions, procedures, instructions and explanations are indistinguishable. Within the application, patients of the sham group will receive a hyperthermia application almost without overheating. In order to achieve this, the patients will be positioned on the IRATHERM®1000 in accordance with the Von Ardenne Institute's regulations. Due to the insulating blanket and the natural device and body heat, the patients of the sham group experience a gentle warmth, which is not the same as regular whole-body hyperthermia and an increase in the body core temperature of about 1.5 °C. In the sham setting, the core body temperature increases by about 0.3 to 0.4 °C within a 55-minute session.

Other: sham group

Interventions

mild hyperthermia group OTHER

The hyperthermia treatment is carried out in a cycle of two treatments per week, with at least one day in between, over a period of two weeks, according to the manufacturer's instructions. For better tolerability, the application takes place under administration of 10L/min oxygen. According to the guidelines, the rectal (possibly vaginal) temperature (as body core temperature), heart rate and oxygen saturation (Sp02) are continuously determined during the hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.

mild hyperthermia group

sham group OTHER

Within the application, patients in the Sham group will undergo a hyperthermia application with virtually no overheating. To achieve this, the patients are positioned on the hyperthermia device in the same way as the intervention group. An insulating foil applied beforehand prevents direct irradiation with water-filtered infrared-A radiation. This prevents an increase in temperature. Due to the insulating blanket and the natural heat from the device and body, patients in the Sham group experience a gentle warmth that cannot be compared with regular whole-body hyperthermia and an increase in core body temperature of around 1.5°C. The number of treatments, the lighting conditions and procedures including 10L/min oxygen supply, is equal to the treatments in the intervention group.

sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 75 years
• Confirmed diagnosis of post-COVID syndrome
• Fatigue: at least 51.5 points on the MFI-20 scale.
• Signed declaration of consent

You may not qualify if:

• Participation in other clinical studies
• Contraindications for hyperthermia (severe cardiovascular diseases with/above NYHA II, active tumor diseases, acute infections, hyperthyroidism (not adjusted), pregnant and breastfeeding women, epilepsy, high-grade cardiac arrhythmia including atrial fibrillation, multiple sclerosis, major skin lesions, photosensitivity disease, acute exacerbated bronchial asthma/COPD \[Gold II to IV\])
• Pleuritic chest pain
• Hyperthyroidism
• Poorly controlled diabetes mellitus
• Condition after critical illness due to COVID-19
• Patients with active tumor disease, with pneumological, rheumatic, endocrine or neurological concomitant diseases (including dementia, epilepsy, multiple sclerosis), in particular neurological diseases associated with cognitive or sensory disorders
• Severe liver or kidney diseases (liver cirrhosis, post liver transplant, autoimmune hepatitis, dialysis patients, post kidney transplant, acute kidney failure, autoimmune nephropathy)
• Patients with chronic cannabis use (exception: CBD for myalgia), long-term use of WHO class III opioids (e.g. for myalgia/joint pain), long-term use of immunosuppressive medication (steroids, biologics, MTX, leflunomide, azathioprine)
• Patients with psychiatric disorders (bipolar disorder, psychosis, schizophrenia, personality disorder)

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Bavarian State Ministry of Health and Care: collaborator

Study Sites (1)

Sozialstiftung Bamberg

Bamberg, Germany

Location

MeSH Terms

Conditions

Hyperthermia; Fatigue

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Jost Langhorst, Prof. Dr.

  Sozialstiftung Bamberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 12, 2024
• Study Start: February 20, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-10

Locations

DE (1)