Sleep Disturbances and Chronic Widespread Pain

Sleep Disturbance Clinical Trial

— POSEIDON  

Official title:

Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03908905
• Other study ID #: 2019-00018
• Status: Suspended
• Start date: September 1, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 96
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic Widespread Pain

Exclusion Criteria:

• Other untreated and or serious psychiatric or somatic conditions

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Widespread Pain
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Diagnostic Test:
• Polysomnography
Sleep screening, neurocognitive assessment, activity monitoring questionnaires, blood sample

Locations

Country	Name	City	State
Sweden	Uppsala university hospital	Uppsala	Uppsala Län

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	Assessment of objective sleep problems	6 months
Secondary	CANTAB	Neurocognitive screening	6 months
Secondary	Actigraph	Activity level	6 months
Secondary	Biomarkers	92-plex inflammatory panel	6 months
Secondary	Pain level	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
Secondary	Fatigue	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