NCT03072745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

March 2, 2017

Last Update Submit

March 2, 2017

Conditions

Chronic PainInsomnia

Keywords

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Memory impairment

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

    1 day

Secondary Outcomes (1)

  • Executive functioning impairment

    1 day

Study Arms (1)

Neuropsychological assessment

EXPERIMENTAL

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

Diagnostic Test: Neuropsychological assessment

Interventions

Neuropsychological assessmentDIAGNOSTIC_TEST

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

Neuropsychological assessment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attending tertiary chronic pain management

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Chronic PainSleep Initiation and Maintenance DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Torsten Gordh, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 7, 2017

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

SE(1)