Trials Sponsors Conditions Drugs Pricing

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.

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 artisOther

Adequate treatment of sleep disorders at Sleep clinic

Treatment lege artis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years - 70 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemale participants

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Fibromyalgia according to 1990 and 2016 ACR (American College of Rheumatology criteria)

Sponsors & Collaborators

Uppsala University
Otherlead

Study Sites (1)

Pain center

Uppsala, 75659, Sweden

MeSH Terms

Conditions

FibromyalgiaSleep Wake DisordersInflammation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPathologic 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

Actual (reported)

Primary Completion

September 4, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Fibromyalgia and Sleep Disorder Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (1)

Treatment lege artis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (1)

Treatment lege artis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations