Fibromyalgia and Sleep Disorder Treatment

Not Applicable

• Conditions: Fibromyalgia; Sleep Disorder

• Registration Number: NCT06786845
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2024-09-04
• Study First Submitted: 2024-11-19
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-09-04
• Study Completion: 2027-04-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in sleep quality	4 months	Change in subjective sleep disturbance measured by Pittsburgh Sleep Quality Index, a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Every item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Change in daytime sleepiness	4 months	Change in sleepiness measured by Epworth Sleepiness Scale, a self-administered questionnaire with 8 questions. Rate, on a 4-point scale (0-3), rik of falling asleep while engaging in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher daytime speepiness.
Change in objective sleep disturbance	4 months	Change in objective sleep disturbance measured by 1-night ambulatory polysomnography. A polysomnogram is the gold standard test to help diagnose sleep disorders. It involves measuring brain wave activity, eye, and limb movements whilst monitoring the breathing pattern and pulse rate during sleep. It is a non-invasive test which requires several sensors and electrodes to be placed on specific points of the body.
Change in pain intensity after adequate treatment of sleep disorder	4 months	measured by Visual Analog Scale, total scores range from 0 to 10 - with a higher score indicating more severe pain (VAS 0 no pain - VAS 10 severe pain)

Secondary Outcome Measures

Name	Time	Method
Change in disease burden	4 months	Change in disease burden measured by Fibromyalgia Impact Questionnaire, a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. A higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. The maximum possible score is 100.

Trial Locations

Locations (1)

Pain center; 🇸🇪 Uppsala, Sweden