Fibromyalgia and Sleep Disorder Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment lege artis.
- Who it may be relevant to
- Registry conditions: Fibromyalgia, Sleep Disorder. Basic parameters: 20 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
How is the Pain Experience in Fibromyalgia Affected by the Treatment of Comorbid, Newly Diagnosed Sleep Disorder? a Longitudinal Study (HOPES)
Overview
This longitudinal study will investigate impact of improved sleep quality on chronic pain, fibromyalgia and how the disrupted sleep pattern alters the neuroenvironment.
Detailed description
The main aim of this study is to evaluate the interaction between pain and sleep, both directly by comparing outcome measures of pain and sleep, and out of one inflammatory perspective using proteomics analyzes. Currently, there is a need for studies that highlight both the above-mentioned interaction and how the inflammatory response in the central nervous system as well as in the systemic circulation is involved. The cohort in existing study (FINE study) is already being used to find associations between these, but as it is a cross-sectional study, the design cannot determinate the causality. The implementation of a longitudinal study where sleep is the single parameter that is modified would add an invaluable scientific basis for the assessment of this complex interplay. Because FINE study also has measurements of both systemic as central immunoactivity, the scientific value becomes very high, and can potentially be helpfull in understanding what happens to pain when sleep is affected, and which immune mediators that are relevant in that dynamic. If it turns out that the treatment of sleep disorders is effective from a pain perspective, it would in addition bring a whole new line of treatment options in fibromyalgia, and emphasize the importance of implementation a proper sleep analysis in the investigation phase for this patient group.
Interventions
- Other Treatment lege artis
Adequate treatment of sleep disorders at Sleep clinic
Primary outcome measures
- Changes in sleep quality [Time frame: 4 months]
- Change in pain intensity after adequate treatment of sleep disorder [Time frame: 4 months]
- Change in daytime sleepiness [Time frame: 4 months]
- Change in objective sleep disturbance [Time frame: 4 months]
Secondary outcome measures (1)
- Change in disease burden [Time frame: 4 months]
Eligibility criteria
Inclusion criteria
- Fibromyalgia according to 1990 and 2016 ACR (American College of Rheumatology criteria)
- Included in FINE study
- Sleep disorder
Exclusion criteria
- Other autoimmune or neuroinflammatory diseases than FM.
- Other dominating pain conditions other than FM (e.g., severe pain due to osteoarthritis, disc herniations etc).
- Severe somatic or psychiatric diseases that would preclude participation or influence results (e.g., cancer, infectious diseases etc).
- Pregnancy.
- Inability to speak and understand Swedish.
- Treatment with anticoagulants.
- High intracranial pressure.
- Ongoing infections.
- Hemophilia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Pain center — Uppsala
Identifiers
NCT: NCT06786845 · HOPES