Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06204458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2024-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mild Water-filtered Infrared-A Whole-body Hyperthermia in Patients With Post-COVID Syndrome (HyPoCo)
Sponsor:
Universität Duisburg-Essen
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of Mild Water-filtered Infrared-A Whole-body Hyperthermia to Improve Symptoms and Quality of Life in Patients With Post-COVID Syndrome (HyPoCo)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HyPoCo
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.
Detailed Description:
A total of about 60 participants over 18 years of age are sought, who will be divided into two groups of equal size after inclusion in the study. All participants will receive the same amount of water-filtered whole-body hyperthermia (WBH) under application of 10 L/min oxygen within the outpatient setting. One group receives the gentle form of WBH, the other group receives the classic, mild WBH, which differ in the intensity of the radiation. Gentle hyperthermia serves as a control group for mild hyperthermia.
All abnormalities are documented by the responsible therapists, doctors and nurses.
Blood parameters are collected before the start, after 2 applications and after the last application during the clinical stay. The aim here is to determine the differential blood count and inflammatory and immune parameters; among other things, autoantibody production is to be examined and monitored during the course of the study. In order to check the possible effectiveness of the treatment, various questionnaire values are also collected. The survey will take place at 3 points in time (at the beginning, after completion of the 4 treatments and 3 months afterwards).
In addition, a diary will be filled out in which patients will provide information on their sleep, personal energy level and pain level as well as their daily step count in order to create an activity profile. All patients receive a paper diary and a pedometer adapted to their individual characteristics in advance. The diary is to be kept from week 0 to week 15.
After completion of the study, qualitative interviews lasting around 30-45 minutes will be conducted with 16-20 participants in weeks 8-10 of the follow-up period. Participants are selected on the basis of socio-demographic and clinical characteristics with the aim of obtaining a sample that is as heterogeneous as possible. The interviews are conducted by telephone.
All abnormalities are documented by the responsible therapists, doctors and nurses.
Blood parameters are collected before the start, after 2 applications and after the last application during the clinical stay. The aim here is to determine the differential blood count and inflammatory and immune parameters; among other things, autoantibody production is to be examined and monitored during the course of the study. In order to check the possible effectiveness of the treatment, various questionnaire values are also collected. The survey will take place at 3 points in time (at the beginning, after completion of the 4 treatments and 3 months afterwards).
In addition, a diary will be filled out in which patients will provide information on their sleep, personal energy level and pain level as well as their daily step count in order to create an activity profile. All patients receive a paper diary and a pedometer adapted to their individual characteristics in advance. The diary is to be kept from week 0 to week 15.
After completion of the study, qualitative interviews lasting around 30-45 minutes will be conducted with 16-20 participants in weeks 8-10 of the follow-up period. Participants are selected on the basis of socio-demographic and clinical characteristics with the aim of obtaining a sample that is as heterogeneous as possible. The interviews are conducted by telephone.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: