Contribution of sleep-related biomarkers to the pathophysiology of ME/CFS: Linking neuronal function to vascular pathology

Contribution of sleep-related biomarkers to the pathophysiology of ME/CFS: Linking neuronal function to vascular pathology - SLEEP-NEURO-PATH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036774

Enrollment

150

Registered

2025-05-20

Start date

2025-05-30

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G93.3

Interventions

Group 1: 75 patients with ME/CFS according to the Canadian criteria, including 50 adult patients and 25 patients aged 12-17 years (Comparison to 50 adult and 25 teenager-aged healthy control subjects)

Eligibility

Sex/Gender

All

Age

12 Years to 65 Years

Inclusion criteria

Inclusion criteria: - ME/CFS according to the Canadian criteria for ME/CFS

Exclusion criteria

Exclusion criteria: - Non-removable electrical implants - Metal implants made of non-MRI-compatible material that cannot be removed • Permanent make-up • Claustrophobia • Pregnancy • Tattoos within 30 cm of the head • Presence of a neuropsychiatric disorder (in patients: except ME/CFS) • Presence of a neurodegenerative disease / dementia • Presence of any other serious illness (in patients: except ME/CFS) • Acute suicidality • Current intake of benzodiazepines, benzodiazepine receptor agonists, or antipsychotics • Drug abuse

Design outcomes

Primary

Measure	Time frame
Reduced sleep spindle density (sleep EEG biomarker measured by polysomnography, PSG), sleep-related breathing disorders (measured by PSG) and dysautonomia (heart rate variability (HRV) during sleep, measured by PSG) are neurophysiological biomarkers of central nervous system (CNS) dysfunction in ME/CFS, with sleep spindle density correlating negatively with cognitive impairment (measured by CAMCOG testing).	—

Measure

Time frame

Reduced sleep spindle density (sleep EEG biomarker measured by polysomnography, PSG), sleep-related breathing disorders (measured by PSG) and dysautonomia (heart rate variability (HRV) during sleep, measured by PSG) are neurophysiological biomarkers of central nervous system (CNS) dysfunction in ME/CFS, with sleep spindle density correlating negatively with cognitive impairment (measured by CAMCOG testing).

—

Secondary

Measure	Time frame
A) Neurophysiological findings and cognitive dysfunction are associated with imaging correlates of CNS vascular pathology (arterial spin labeling (ASL) blood flow measurements and diffusion tensor imaging (DTI), in subgroup of 50 adult patients and 50 control subjects) and impaired neuronal energy metabolism (31P MR spectroscopic imaging at 7T, in subgroup of 25 adult patients and 25 control subjects). B) The interaction of vasoregulatory GPCR autoantibodies with serum markers of endothelial dysfunction and/or tissue hypoxia predicts sleep-related neurophysiological correlates of impaired brain function (total sample).	—

Measure

Time frame

A) Neurophysiological findings and cognitive dysfunction are associated with imaging correlates of CNS vascular pathology (arterial spin labeling (ASL) blood flow measurements and diffusion tensor imaging (DTI), in subgroup of 50 adult patients and 50 control subjects) and impaired neuronal energy metabolism (31P MR spectroscopic imaging at 7T, in subgroup of 25 adult patients and 25 control subjects). B) The interaction of vasoregulatory GPCR autoantibodies with serum markers of endothelial dysfunction and/or tissue hypoxia predicts sleep-related neurophysiological correlates of impaired brain function (total sample).

—

Countries

Germany

Contacts

Public ContactClaudia Schilling

Zentralinstitut für Seelische Gesundheit

claudia.schilling@zi-mannheim.de+4962117031781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026