Status:
UNKNOWN
Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Brief Summary
Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances. The frequency of nocturnal problems has been reported to be higher in COPD than in the general population a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with written inform consent to participate in the study and all the following criteria will be selected:
- Age 40-80 years
- Smokers or exsmokers of at least 10 pack-years
- Moderate-to-severe COPD
- Exclusion criteria:
- Non-stable COPD. Stability is defined as being exacerbation free and without treatment changes for at least 4 weeks prior to baseline evaluation. The presence of a COPD exacerbation previous to the sleep studies (polysomnography, actigraphy, OSLER test) will lead to an early discontinuation of the patient´s participation in the study.
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03290014
Start Date
March 1 2017
End Date
September 30 2018
Last Update
September 21 2017
Active Locations (1)
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1
Hospital Universitari Vall d´Hebron
Barcelona, Spain, 08034