Sleep Disturbances and Chronic Widespread Pain

Suspended

• Conditions: Chronic Widespread Pain; Sleep Disturbance
• Interventions: Diagnostic Test: Polysomnography

• Registration Number: NCT03908905
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Study Start: 2019-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Chronic Widespread Pain

Exclusion Criteria

• Other untreated and or serious psychiatric or somatic conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Polysomnography	-

Primary Outcome Measures

Name	Time	Method
Polysomnography	6 months	Assessment of objective sleep problems

Secondary Outcome Measures

Name	Time	Method
CANTAB	6 months	Neurocognitive screening
Actigraph	6 months	Activity level
Biomarkers	6 months	92-plex inflammatory panel
Pain level	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.
Fatigue	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.

Trial Locations

Locations (1)

Uppsala university hospital; 🇸🇪 Uppsala, Uppsala Län, Sweden