Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Disturbances and Chronic Widespread Pain (POSEIDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908905
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2019
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Chronic Widespread Pain Sleep Disturbance Diagnostic Test: Polysomnography

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Polysomnography [ Time Frame: 6 months ]
    Assessment of objective sleep problems


Secondary Outcome Measures :
  1. CANTAB [ Time Frame: 6 months ]
    Neurocognitive screening

  2. Actigraph [ Time Frame: 6 months ]
    Activity level

  3. Biomarkers [ Time Frame: 6 months ]
    92-plex inflammatory panel

  4. 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.

  5. 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.


Biospecimen Retention:   Samples Without DNA
Plasma

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • Chronic Widespread Pain

Exclusion Criteria:

  • Other untreated and or serious psychiatric or somatic conditions
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908905


Locations
Layout table for location information
Sweden
Uppsala university hospital
Uppsala, Uppsala Län, Sweden, 752 60
Sponsors and Collaborators
Uppsala University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03908905    
Other Study ID Numbers: 2019-00018
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Pain
Sleep
Neuropsychology
Fatigue
 Activity level
Attention
Executive function
Memory
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyssomnias
Parasomnias
Chronic Pain
Sleep Wake Disorders
 Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Pain