Chronic Fatigue Syndrome in AdolescencePOTS-CFSNCT06054958
POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS
An observational study of Chronic Fatigue Syndrome in Adolescence and Postural Orthostatic Tachycardia Syndrome, run by Technical University of Munich at 1 site in Germany.
Trial summary
Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC). Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome in Adolescence, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2021to 22 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents with ME/CFS and healthy controls
Who may be able to join
- Cases (ME/CFS):
- ME/CFS diagnosed by the indicated clinical criteria
- Healthy Controls
- clinically healthy
- no known underlying disease
- no prescription medication (except contraception)
Who cannot join
- Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
- pregnancy
- breastfeeding.
Trial locations and contacts
1 site in 1 country.
Germany1 site
MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich
Munich, Bavaria, 80804
About this study
Official title: POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS
Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).
Read the detailed description
ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent.
This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics.
ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication.
Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.
- Conditions
- Chronic Fatigue Syndrome in Adolescence, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ME/CFS | ME/CFS: adolescents aged 14-17 years, fulfilling diagnostic criteria for ME/CFS according to Rowe e 2017, Jason 2006, CCC 2003, and/ or IOM 2015 at the time of recruitment. Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling. | |
| Healthy Controls (HC) | HC: adolescents aged 14-17, clinically healthy without any known underlying disease and with no prescription drugs (except contraception). Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate during Passive 10-min. standing test
Heart rate during Passive 10-Min. standing test (NASA lean test)
Measured: one time point during study from study start until study completion, approximately 1 year
Blood Pressure during Passive 10-min. standing test
blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)
Measured: one time point during study from study start until study completion, approximately 1 year
Symptoms during Passive 10-Min. standing test
Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No
Measured: one time point during study from study start until study completion, approximately 1 year
O2-Saturation during Passive 10-Min. standing test
O2-Saturation during Passive 10-Min. standing test (NASA lean test)
Measured: one time point during study from study start until study completion, approximately 1 year
Presence of Orthostatic Intolerance: Semistructured Interview
Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No
Measured: one time point during study from study start until study completion, approximately 1 year
Number of orthostatic Symptoms: Semistructured Interview
Semistructured Interview, Number of Symptoms
Measured: one time point during study from study start until study completion, approximately 1 year
Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses
History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated
Measured: one time point during study from study start until study completion, approximately 1 year
Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)
Questionnaire: number of relevant symptoms. Likert Scale "0-4" of severity and frequency for each symptom: A symptom is relevant with a severity and frequency of each at least "2" on the Likert Scale. Minimum: 0 relevant symptoms (best), Maximum: 60 relevant symptoms (worst).
Measured: one time point during study from study start until study completion, approximately 1 year
Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)
Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No
Measured: one time point during study from study start until study completion, approximately 1 year
Self-estimated level of Quality of Life: EQ-5D-5L: Index
Questionnaire: Index (0 worst - 1 best)
Measured: one time point during study from study start until study completion, approximately 1 year
Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale
Visual Analog Scale (0 worst - 100 best)
Measured: one time point during study from study start until study completion, approximately 1 year
Screening via Public Health Questionnaire-4 (PHQ-4)
Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)
Measured: one time point during study from study start until study completion, approximately 1 year
Malmö PoTS Score (MAPS)
Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)
Measured: one time point during study from study start until study completion, approximately 1 year
Secondary outcomes (3)
Levels of serum antibodies against EBV
Levels of Autoantibodies at study visit
Measured: one time point during study from study start until study completion, approximately 1 year
Levels of serum antibodies against SARS-CoV-2
Levels of autoantibodies at study visit
Measured: one time point during study from study start until study completion, approximately 1 year
Levels of serum autoantibodies
Levels of autoantibodies at study visit
Measured: one time point during study from study start until study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start6 Dec 2021
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue Syndrome in AdolescenceStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Aachen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054958
- Sponsor's protocol ID
- POTS-CFS
- Acronym
- POTS-CFS
- Status last verified
- Jul 2023
- First submitted
- 16 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS
- ClinicalTrials.gov ID
- NCT06054958
- Acronym / sponsor ID
- POTS-CFS / POTS-CFS
- Conditions
- Chronic Fatigue Syndrome in Adolescence, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- University Hospital, Aachen
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls (HC).
Detailed description
ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and social participation. Yet, data in affected adolescents are rare and inconsistent.
This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17 years with ME/CFS and age-adapted HC, comparing the results with other clinical features of both such as exertion intolerance, fatigue, and health-related quality of life, and suggesting a standardized tool for diagnostics.
ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017, and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related quality of life. A standardized specific interview was performed to assess the medical history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a passive 10-min standing test (NASA lean test) in the morning with empty stomach and without morning medication.
Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes of Health Expert Consensus Meeting and by the International Classification of Diseases (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and outcomes compared to parameters from questionnaires. Based on the results, novel standards for OI diagnostics were suggested.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME/CFS | – | –ME/CFS: adolescents aged 14-17 years, fulfilling diagnostic criteria for ME/CFS according to Rowe e 2017, Jason 2006, CCC 2003, and/ or IOM 2015 at the time of recruitment. Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling. |
| Healthy Controls (HC) | – | –HC: adolescents aged 14-17, clinically healthy without any known underlying disease and with no prescription drugs (except contraception). Methods: Semi-structured interview, questionnaires, passive 10-minute standing test (NASA lean test), blood sampling. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents with ME/CFS and healthy controls
Key inclusion criteria (6 listed)
- Cases (ME/CFS):
- Healthy Controls
Key exclusion criteria (3 listed)
- Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
- pregnancy
- breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate during Passive 10-min. standing test
Time frame: one time point during study from study start until study completion, approximately 1 year
Heart rate during Passive 10-Min. standing test (NASA lean test)
Blood Pressure during Passive 10-min. standing test
Time frame: one time point during study from study start until study completion, approximately 1 year
blood pressure, pulse pressure (calculated by systolic and diastolic blood pressure) during Passive 10-Min. standing test (NASA lean test)
Symptoms during Passive 10-Min. standing test
Time frame: one time point during study from study start until study completion, approximately 1 year
Symptoms during Passive 10-Min. standing test (NASA lean test): Yes/No
O2-Saturation during Passive 10-Min. standing test
Time frame: one time point during study from study start until study completion, approximately 1 year
O2-Saturation during Passive 10-Min. standing test (NASA lean test)
Presence of Orthostatic Intolerance: Semistructured Interview
Time frame: one time point during study from study start until study completion, approximately 1 year
Semistructured Interview, History of Orthostatic Intolerance (OI): Yes/No
Number of orthostatic Symptoms: Semistructured Interview
Time frame: one time point during study from study start until study completion, approximately 1 year
Semistructured Interview, Number of Symptoms
Number of participants with a diagnosis of PoTS, Orthostatic Intolerance and related diagnoses
Time frame: one time point during study from study start until study completion, approximately 1 year
History of OI and Nasa lean test together result in an orthostatic diagnosis, Fulfilling of PoTS-Criteria at study visit is evaluated
Presence of ME/CFS-specific Symptoms (Munich Berlin Symptom Questionnaire)
Time frame: one time point during study from study start until study completion, approximately 1 year
Questionnaire: number of relevant symptoms. Likert Scale "0-4" of severity and frequency for each symptom: A symptom is relevant with a severity and frequency of each at least "2" on the Likert Scale. Minimum: 0 relevant symptoms (best), Maximum: 60 relevant symptoms (worst).
Presence of Post-exertional malaise (DePaul Symptom Questionnaire -Post exertional Malaise: DSQ-PEM)
Time frame: one time point during study from study start until study completion, approximately 1 year
Questionnaire, Binary Outcome: Post-exertional Malaise Yes/No
Self-estimated level of Quality of Life: EQ-5D-5L: Index
Time frame: one time point during study from study start until study completion, approximately 1 year
Questionnaire: Index (0 worst - 1 best)
Self-estimated level of Quality of Life: EQ-5D-5L: Visual Analog Scale
Time frame: one time point during study from study start until study completion, approximately 1 year
Visual Analog Scale (0 worst - 100 best)
Screening via Public Health Questionnaire-4 (PHQ-4)
Time frame: one time point during study from study start until study completion, approximately 1 year
Ultra-Short-4-item-Screening for Anxiety/Depression: Scale (0 Symptom occurs never - 3 Symptom occurs almost every day)
Malmö PoTS Score (MAPS)
Time frame: one time point during study from study start until study completion, approximately 1 year
Orthostatic Symptoms Severity, Scale (0 no symptom burden - 120 highest symptom burden)
3 secondary outcomes
Levels of serum antibodies against EBV
Time frame: one time point during study from study start until study completion, approximately 1 year
Levels of serum antibodies against SARS-CoV-2
Time frame: one time point during study from study start until study completion, approximately 1 year
Levels of serum autoantibodies
Time frame: one time point during study from study start until study completion, approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome in Adolescence and Postural Orthostatic Tachycardia Syndrome, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate during Passive 10-min. standing test (time frame: one time point during study from study start until study completion, approximately 1 year). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.