Fibromyalgia and Sleep Disorder Treatment (HOPES)

How is the Pain Experience in Fibromyalgia Affected by the Treatment of Comorbid, Newly Diagnosed Sleep Disorder? a Longitudinal Study (HOPES)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep Disorder; Fibromyalgia
• Intervention / Treatment: Other: Treatment lege artis

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75659
    • Pain center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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).

Other: Treatment lege artis; Adequate treatment of sleep disorders at Sleep clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sleep quality	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.	4 months
Change in pain intensity after adequate treatment of sleep disorder	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)	4 months
Change in daytime sleepiness	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.	4 months
Change in objective sleep disturbance	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disease burden	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.	4 months

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Romana Stehlik, PhD, Pain center

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): September 4, 2025
• Study Completion (Estimated): April 12, 2027

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Mental Disorders; Neuromuscular Diseases; Rheumatic Diseases; Parasomnias; Fibromyalgia; Myofascial Pain Syndromes; Sleep Wake Disorders
• Other Study ID Numbers: HOPES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial
• IPD Sharing Time Frame: Q2 2025 - Q2 2027
• IPD Sharing Access Criteria: Analyses data - SPSS. Data sharing agreement must be signed and PI will review the review requests
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No