Fibromyalgia and Sleep Disorder Treatment (HOPES)

Uppsala University

Status: Invitation-only

Conditions: Fibromyalgia; Sleep Disorder

Treatments: Other: Treatment lege artis

Study type: Interventional

Funder types: Other

Identifiers

NCT06786845

HOPES

Details and patient eligibility

About

This longitudinal study will investigate impact of improved sleep quality on chronic pain, fibromyalgia and how the disrupted sleep pattern alters the neuroenvironment.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Treatment lege artis

Other group

Description:

Recruited individuals in the cohort undergoe adequate treatment of the sleep disorder initiated by the sleep specialist at the sleep clinic, and when subjects are considered well treated, the sleep investigation is repeated in connection with follow-up 2-4 months later. Sleep duration and physical activity are measured with an actigraph for 10 days after the first visit when sleep treatment was initiated and 10 days before the follow-up, when the sleep intervention is complete. Treatment of sleep disorders is carried out according to lege artis at the sleep clinic at the Pain Center (obstructive sleep apnea syndrome, snoring, restless legs syndrom and periodic limb movements, circadian rhythm disorders, insomnia) and examination of pain intensity before (as part of the FINE study) and after treatment is carried out with pain assessment (quantitatory sensory testing and conditioned pain modulation as well as a new panel with inflammatory markers and lumbal puncture).

Treatment:

Other: Treatment lege artis