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Making it Personal: Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Insights from N-of-1 Studies: A Series of N-of-1 Observational Studies

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001898246
Enrollment
20
Registered
2018-11-22
Start date
2025-01-01
Completion date
2025-09-30
Last updated
2024-12-02

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

Conditions

None listed

Brief summary

This research study aims to explore intra-individual variability in symptoms over time and intra-individual predictors of symptom severity. A series of n-of-1 observational studies with individuals with ME/CFS will be conducted. The study also aims to assess the acceptability and feasibility of participating in n-of-1 observational studies from the perspective of individuals with ME/CFS. This will be achieved by conducting semi-structured interviews with participants at the end of the study and by examining participant adherence to study procedures (e.g. questionnaire completion rates).

Interventions

ME/CFS is a complex, multi-system, neuroimmune condition with a multitude of symptoms. Some symptoms include post-exertional fatigue/malaise, sleep problems/disturbances, joint and muscle pain, headaches, short-term memory loss, impaired concentration, hypersensitivity to light and sound, emotional overload, problems with dizziness and balance, recurrent flu-like symptoms, gastrointestinal problems and sensitivities to food, medications, odours or certain chemicals. It is common for patients to

ME/CFS is a complex, multi-system, neuroimmune condition with a multitude of symptoms. Some symptoms include post-exertional fatigue/malaise, sleep problems/disturbances, joint and muscle pain, headaches, short-term memory loss, impaired concentration, hypersensitivity to light and sound, emotional overload, problems with dizziness and balance, recurrent flu-like symptoms, gastrointestinal problems and sensitivities to food, medications, odours or certain chemicals. It is common for patients to experience post-exertional fatigue/malaise, but the particular cluster of symptoms experienced can differ considerably from one person to another. Factors such as physical/cognitive activity, sleep, stress and mood may trigger or worsen symptoms. In this study, variables including physical/cognitive activity, sleep, stress, mood and fatigue are measured on a daily basis for period of 6-12 weeks via an electronic diary with an inbuilt accelerometer. Variables related to personally-relevant symptoms (e.g. body pain, headaches, dizziness) and potential triggers of symptoms (e.g. emotional distress, dehydration) are selected by participants at the start of the study and also added to the daily questionnaires.

Sponsors

The University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults 18 years or older with a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Individuals are not excluded on the basis of their gender, age or overall health status.

Exclusion criteria

Individuals under 18 years old. Individuals who have not received a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026