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Completed

NCT Number: NCT06054958

POTS-CFS Study: 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).

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Key information

Conditions

Chronic Fatigue Syndrome in Adolescence Autonomic Nervous System Diseases Nervous System Diseases Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias Signs and Symptoms

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MRI Chronic Fatigue Center for Young People (MCFC) Children's Hospital, Technical University of Munich & Munich Municipal Hospital Munich

Munich, Bavaria, 80804, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cases (ME/CFS):
  • ME/CFS diagnosed by the indicated clinical criteria
  • Healthy Controls
  • clinically healthy
  • no known underlying disease
  • no prescription medication (except contraception)

Exclusion criteria

  • Any contraindication for NASA lean test (cardiac failure, severe aortic stenosis, inability to stand)
  • pregnancy
  • breastfeeding.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

Secondary outcomes

  1. Levels of serum antibodies against EBV

    Time frame: one time point during study from study start until study completion, approximately 1 year

    Levels of Autoantibodies at study visit

  2. 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 autoantibodies at study visit

  3. Levels of serum autoantibodies

    Time frame: one time point during study from study start until study completion, approximately 1 year

    Levels of autoantibodies at study visit

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • University Hospital, Aachen

Registry information

Official study title

POTS-CFS Study: A Case-Control Study on Exertion and Orthostatic Intolerance in the Context of Pediatric ME/CFS

Acronym: POTS-CFS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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