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

NCT06204458 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-11

No results posted yet for this study

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

Interventions

OTHER

mild hyperthermia group

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.

OTHER

sham group

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.

Sponsors & Collaborators

  • Bavarian State Ministry of Health and Care

    collaborator OTHER_GOV

  • Universität Duisburg-Essen

    lead OTHER

Principal Investigators

  • Jost Langhorst, Prof. Dr. · Sozialstiftung Bamberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204458 on ClinicalTrials.gov