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OpenTrials
Completed

NCT Number: NCT02585609

Sleep Quality in Patients With Advanced Cancer

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.

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Key information

Conditions

Sleep Disorders Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institutt for sirkulasjon og bildediagnostikk

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. total sleep time

    Time frame: 24 hours

    1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Sleep Quality in Patients With Advanced Cancer. A Comparison of Objective Assessments and Self-reports of Sleep Quality

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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