Sleep Disturbances and Chronic Widespread Pain (POSEIDON)

February 27, 2024 updated by: Uppsala University

Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Uppsala Län
      • Uppsala, Uppsala Län, Sweden, 752 60
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  • Chronic Widespread Pain

Exclusion Criteria:

  • Other untreated and or serious psychiatric or somatic conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Diagnostic test: Polysomnography
Sleep screening, neurocognitive assessment, activity monitoring questionnaires, blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography
Time Frame: 6 months
Assessment of objective sleep problems
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CANTAB
Time Frame: 6 months
Neurocognitive screening
6 months
Actigraph
Time Frame: 6 months
Activity level
6 months
Biomarkers
Time Frame: 6 months
92-plex inflammatory panel
6 months
Pain level
Time Frame: 6 months
The Brief Pain Inventory - Short Form, BPI, a 9 item (0-10) self-administered questionnaire, assessing the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Maximum total score possible is 90. Higher the score, greater the degree of disability.
6 months
Fatigue
Time Frame: 6 months
Fatigue severity scale, FSS, a 9 item self-administered questionnaire assessing severity of fatigue and how fatigue interferes with activity. Items are scored on a 7 point scale, minimum total score possible is 9 and maximum 63. Higher the score, greater the severity.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Widespread Pain

Clinical Trials on Polysomnography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe