POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS

NCT06054958 | Completed DMC

• 1 other identifier: POTS-CFS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Fatigue Syndrome in Adolescence; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Outcome Measures

Primary Outcomes (13)

• Heart Rate during Passive 10-min. standing test

  Heart rate during Passive 10-Min. standing test (NASA lean test)

  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)

  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

  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)

  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

  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

  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

  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).

  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

  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)

  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)

  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)

  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)

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

Secondary Outcomes (3)

• Levels of serum antibodies against EBV

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

• Levels of serum antibodies against SARS-CoV-2

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

• Levels of serum autoantibodies

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with ME/CFS and healthy controls

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead
• University Hospital, Aachen: collaborator

Study Sites (1)

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

Munich, Bavaria, 80804, Germany

Location

Related Links

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MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 26, 2023
• Study Start: December 6, 2021
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-07

Locations

DE (1)