Insomnia and Cognitive Performance in Chronic Pain

March 2, 2017 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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, Sweden, 75185
        • Uppsala University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending tertiary chronic pain management

Exclusion Criteria:

  • None

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuropsychological assessment
Assessment with a neuropsychological test battery and self-report measures.
Diagnostic test: Neuropsychological assessment
Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory impairment
Time Frame: 1 day
Composite score comprising verbal working memory, verbal retention, and visuospatial retention.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive functioning impairment
Time Frame: 1 day
Composite score comprising cognitive flexibility and sustained attention.
1 day

Collaborators and Investigators

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

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Torsten Gordh, PhD, 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)

January 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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