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Insomnia and Cognitive Performance in Chronic Pain

Primary Purpose

Chronic Pain, Insomnia

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Neuropsychological assessment

About this trial

This is an interventional screening trial for Chronic Pain focused on measuring Cognitive Impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Attending tertiary chronic pain management

Exclusion Criteria:

None

Sites / Locations

Uppsala University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuropsychological assessment

Arm Description

Assessment with a neuropsychological test battery and self-report measures.

Outcomes

Primary Outcome Measures

Memory impairment

Composite score comprising verbal working memory, verbal retention, and visuospatial retention.

Secondary Outcome Measures

Executive functioning impairment

Composite score comprising cognitive flexibility and sustained attention.

Full Information

NCT ID

NCT03072745

First Posted

March 2, 2017

Last Updated

March 2, 2017

Sponsor

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT03072745

Brief Title

Insomnia and Cognitive Performance in Chronic Pain

Official Title

Distinct Effect of Insomnia on Cognitive Performance in Individuals With Complex Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

May 1, 2012 (Actual)

Study Completion Date

June 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

Detailed Description

Almost 20 % of the adult European population suffers from chronic pain of moderate to severe intensity, and clinical insomnia has been reported in 53-73% of chronic pain patients. Insomnia seems to be correlated with small to moderate impairments in several cognitive functions involved in working and episodic memory and in attention tasks, and chronic pain has been shown to be associated with objective deficits in memory and executive functioning. The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself. Inividuals with complex chronic pain are assessed with a neuropsychological test battery examining different aspects of memory and executive functioning: The Digit Span subtest from Wechsler's Adult Intelligence Scale III (WAIS-III): Verbal working memory. Claeson-Dahl Inventory of Learning and Memory (CD): Verbal retention. The Rey Complex Figure Test (RCFT): Visuospatial retention. The Wisconsin Card Sorting Test (WCST): Cognitive flexibility. The Trail-Making Test (TMT): Sustained attention. The presence of insomnia is examined with the Bergen Insomnia Scale (BIS) , and insomnia severity with the Insomnia Severity Index (ISI). Present pain level at the time of the neuropsychological assessment is quantified using the Visual Analogue Scale (VAS). Pain medication is transformed to the morphine equivalent daily dose (MEDD). Anxiety and depression are assessed with the Hospital Anxiety and Depression Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Insomnia

Keywords

Cognitive Impairment

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neuropsychological assessment

Arm Type

Experimental

Arm Description

Assessment with a neuropsychological test battery and self-report measures.

Intervention Type

Diagnostic Test

Intervention Name(s)

Neuropsychological assessment

Intervention Description

Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning

Primary Outcome Measure Information:

Title

Memory impairment

Description

Composite score comprising verbal working memory, verbal retention, and visuospatial retention.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Executive functioning impairment

Description

Composite score comprising cognitive flexibility and sustained attention.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Attending tertiary chronic pain management Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torsten Gordh, PhD

Organizational Affiliation

Uppsala University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uppsala University

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Insomnia and Cognitive Performance in Chronic Pain

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