Fibromyalgia and Sleep Disorder Treatment

NCT ID: NCT06786845

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2027-04-12

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.

Conditions

Fibromyalgia; Sleep Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment lege artis

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).

Group Type: OTHER

Treatment lege artis

Intervention Type: OTHER

Adequate treatment of sleep disorders at Sleep clinic

Interventions

Treatment lege artis

Adequate treatment of sleep disorders at Sleep clinic

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romana Stehlik, PhD

Role: PRINCIPAL_INVESTIGATOR

Pain center

Locations

Pain center

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

HOPES

Identifier Type: -

Identifier Source: org_study_id