Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)
NCT ID: NCT03290014
Last Updated: 2017-09-21
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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UNKNOWN
58 participants
OBSERVATIONAL
2017-03-01
2018-09-30
Brief Summary
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The CASIS questionnaire includes 7 questions and it has been recently validated as an objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality measured by objective polysomnographic parameters.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Good sleepers
COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
polysomnography
Monitoring of brain activity and respiratory variables during sleep
Actigraphy
monitoring daily physical activity for 7 days
Osler test
Evaluation of subjects´ ability to remain awake
Bad sleepers
COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
polysomnography
Monitoring of brain activity and respiratory variables during sleep
Actigraphy
monitoring daily physical activity for 7 days
Osler test
Evaluation of subjects´ ability to remain awake
Interventions
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polysomnography
Monitoring of brain activity and respiratory variables during sleep
Actigraphy
monitoring daily physical activity for 7 days
Osler test
Evaluation of subjects´ ability to remain awake
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 40-80 years
* Smokers or exsmokers of at least 10 pack-years
* Moderate-to-severe COPD
Exclusion Criteria
* Heart failure, asthma, cancer or other major medical illness with known effects on sleep quality.
* Unable to understanding the questionnaires administered in the study.
* Known Obstructive Sleep Apnea, other sleep disorder (narcolepsy, periodic limb movements) or shift work.
* Chronic respiratory failure (PaO2 \<60 mmHg).
* Treatment with sedatives or antidepressants.
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Marc Miravitlles, PhD
Role: STUDY_CHAIR
Vall d´Hebron Institut de Recerca
Locations
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Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Pokrzywinski RF, Meads DM, McKenna SP, Glendenning GA, Revicki DA. Development and psychometric assessment of the COPD and Asthma Sleep Impact Scale (CASIS). Health Qual Life Outcomes. 2009 Dec 7;7:98. doi: 10.1186/1477-7525-7-98.
Miravitlles M, Iriberri M, Barrueco M, Lleonart M, Villarrubia E, Galera J. Usefulness of the LCOPD, CAFS and CASIS scales in understanding the impact of COPD on patients. Respiration. 2013;86(3):190-200. doi: 10.1159/000341175. Epub 2012 Oct 2.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PR(AG)365/2015
Identifier Type: -
Identifier Source: org_study_id