Fibromyalgia and Sleep Disorder Treatment

NCT06786845 | Enrolling By Invitation

• 1 other identifier: HOPES
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Sleep Disorder

Keywords

Inflammation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Change in disease burden

  4 months

Study Arms (1)

Treatment lege artis

OTHER

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

Interventions

Treatment lege artis OTHER

Adequate treatment of sleep disorders at Sleep clinic

Treatment lege artis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Female participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia according to 1990 and 2016 ACR (American College of Rheumatology criteria)
• Included in FINE study
• Sleep disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Pain center

Uppsala, 75659, Sweden

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Wake Disorders; Inflammation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Study Officials

• Romana Stehlik, PhD

  Pain center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: January 22, 2025
• Study Start: September 4, 2024
• Primary Completion: September 4, 2025
• Study Completion (Estimated): April 12, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Q2 2025 - Q2 2027
• Access Criteria: Analyses data - SPSS. Data sharing agreement must be signed and PI will review the review requests

Locations

SE (1)