Sleep Disturbances and Chronic Widespread Pain

NCT03908905 | Suspended

• 1 other identifier: 2019-00018
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Widespread Pain; Sleep Disturbance

Keywords

Pain; Sleep; Neuropsychology; Fatigue; Activity level; Attention; Executive function; Memory

Outcome Measures

Primary Outcomes (1)

• Polysomnography

  Assessment of objective sleep problems

  6 months

Secondary Outcomes (5)

• CANTAB

  6 months

• Actigraph

  6 months

• Biomarkers

  6 months

• Pain level

  6 months

• Fatigue

  6 months

Study Arms (1)

Intervention

Diagnostic Test: Polysomnography

Interventions

Polysomnography DIAGNOSTIC_TEST

Sleep screening, neurocognitive assessment, activity monitoring questionnaires, blood sample

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects that are referred for an inpatient multidisciplinary analysis of complex chronic pain conditions at a regional pain center at Uppsala University Hospital.

You may qualify if:

• Chronic Widespread Pain

You may not qualify if:

• Other untreated and or serious psychiatric or somatic conditions

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala university hospital

Uppsala, Uppsala County, 752 60, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Chronic Pain; Parasomnias; Pain; Fatigue

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 9, 2019
• Study Start: September 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

SE (1)