Chronic PainNCT03072745
Insomnia and Cognitive Performance in Chronic Pain
A study testing Neuropsychological assessment in people with Chronic Pain and Insomnia, run by Uppsala University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Insomnia
- What is being tested?
- Neuropsychological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2011to 1 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending tertiary chronic pain management
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Insomnia
- Being tested
- Neuropsychological assessment
- Keywords
- Cognitive Impairment
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentDiagnostic test
Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological assessment | Experimental | Assessment with a neuropsychological test battery and self-report measures. Receives: Diagnostic Test: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory impairment
Composite score comprising verbal working memory, verbal retention, and visuospatial retention.
Measured: 1 day
Secondary outcomes (1)
Executive functioning impairment
Composite score comprising cognitive flexibility and sustained attention.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Jan 2011
- Primary completion1 May 2012
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torsten Gordh, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072745
- Sponsor's protocol ID
- 2010/182
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinct Effect of Insomnia on Cognitive Performance in Individuals With Complex Chronic Pain
- ClinicalTrials.gov ID
- NCT03072745
- Acronym / sponsor ID
- 2010/182
- Conditions
- Chronic Pain, Insomnia
- Keywords
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological assessment | Experimental | Diagnostic Test: Neuropsychological assessmentAssessment with a neuropsychological test battery and self-report measures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Attending tertiary chronic pain management
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentAssessment with a neuropsychological test battery examining different aspects of memory and executive functioning | Diagnostic test | Neuropsychological assessment |
Primary outcome
Memory impairment
Time frame: 1 day
Composite score comprising verbal working memory, verbal retention, and visuospatial retention.
1 secondary outcome
Executive functioning impairment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Gordh, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment in people with Chronic Pain and Insomnia, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory impairment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.