Clinical trial NCT06786845: Fibromyalgia and Sleep Disorder Treatment
Official title: How is the Pain Experience in Fibromyalgia Affected by the Treatment of Comorbid, Newly Diagnosed Sleep Disorder? a Longitudinal Study (HOPES)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fibromyalgia
Sleep Disorder
Keywords: Inflammation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Changes in sleep quality
timeFrame: 4 months
measure: Change in pain intensity after adequate treatment of sleep disorder
timeFrame: 4 months
measure: Change in daytime sleepiness
timeFrame: 4 months
measure: Change in objective sleep disturbance
timeFrame: 4 months
Secondary outcomes:
measure: Change in disease burden
timeFrame: 4 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Pain center
Study officials:
affiliation: Pain center
name: Romana Stehlik, PhD
role: PRINCIPAL_INVESTIGATOR
References: