Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2015-10-31
2017-03-10
Brief Summary
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The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Presence of metastatic/disseminated disease
* Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days
* Able to comply with all study procedures
* Signed informed consent according to ICH Good Clinical Practice and national/local regulations
Exclusion Criteria
* Not mastering the language used at the study centre
* Severe cognitive impairment as judged by the principal investigator
* Any reason why, in the opinion of the investigator, the patient should not participate
* Impaired use of the dominant arm
* Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour)
* having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Pål Klepstad, md phd
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Institutt for sirkulasjon og bildediagnostikk
Trondheim, , Norway
Countries
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Other Identifiers
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Sleep study II
Identifier Type: -
Identifier Source: org_study_id
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