Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)

Study Overview
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Brief Summary
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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 and it currently affects up to 50% of patients. 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.

Official Title
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Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study

Conditions
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COPD

Intervention / Treatment
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* Diagnostic Test: polysomnography
* Diagnostic Test: Actigraphy
* Diagnostic Test: Osler test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Good sleepers<br>COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test | Diagnostic Test: polysomnography<br>* Monitoring of brain activity and respiratory variables during sleep<br>Diagnostic Test: Actigraphy<br>* monitoring daily physical activity for 7 days<br>Diagnostic Test: Osler test<br>* Evaluation of subjects´ ability to remain awake<br>* Other names: Oxford sleep resistance test;|
| Bad sleepers<br>COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test | Diagnostic Test: polysomnography<br>* Monitoring of brain activity and respiratory variables during sleep<br>Diagnostic Test: Actigraphy<br>* monitoring daily physical activity for 7 days<br>Diagnostic Test: Osler test<br>* Evaluation of subjects´ ability to remain awake<br>* Other names: Oxford sleep resistance test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Sleep time/Time in bed | One night at the sleep unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | Total sleep time | One night at the sleep unit | 
| Arousal index | number of arousals/hour of sleep | One night at the sleep unit | 
| sleep architecture | percentage of the different sleep phases | One night at the sleep unit | 
| Osler test error index | number of errors | Next morning after polysomnography (8a.m.--4 p.m.) | 
| Actigraphy | Monitoring of rest/activity cycles | One week previous to polysomnography |