Sleep Quality in Patients With Advanced Cancer

Completed

• Conditions: Neoplasms; Sleep Disorders

• Registration Number: NCT02585609
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2017-03-10
• Study Completion: 2017-03-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• A verified diagnosis of a malignant disease
• 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 consenting to participation
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total sleep time	24 hours	1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires

Trial Locations

Locations (1)

Institutt for sirkulasjon og bildediagnostikk; 🇳🇴 Trondheim, Norway