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Clinical Trials/NCT03908905
NCT03908905SuspendedNot Applicable

Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain

Uppsala University1 site in 1 country96 target enrollmentStarted: September 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
Polysomnography

Study Overview

Brief Summary

Chronic widespread pain (CWP), defined as long-lasting pain in multiple body regions, has a prevalence of 10-14% in Europe and is associated with other physical symptoms such as fatigue and cognitive problems. Individuals with longstanding pain also have a high prevalence of sleep disturbances, and sleep problems can in itself lead to tiredness, lower neurocognitive function and higher pain ratings. However, studies of comorbid sleep problems for individuals with CWP are a lacking, and the primary aim for the present study is to assess the prevalence of sleep disturbances in individuals with CWP, and to see how this covariates with pain, fatigue, activity level, neurocognitive functioning, and biomarkers. As a secondary aim the study will assess a subgroup of the individuals, that has received multimodal pain management treatment, a second time after 6 months to analyze how the prevalence of sleep disturbances and other associated problems covaries over time.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic Widespread Pain

Exclusion Criteria

  • Other untreated and or serious psychiatric or somatic conditions

Outcomes

Primary Outcomes

Polysomnography

Time Frame: 6 months

Assessment of objective sleep problems

Secondary Outcomes

  • CANTAB(6 months)
  • Actigraph(6 months)
  • Biomarkers(6 months)
  • Pain level(6 months)
  • Fatigue(6 months)

Investigators

Sponsor
Uppsala University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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