COPD
Conditions
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 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.
Interventions
DIAGNOSTIC_TESTpolysomnography
Monitoring of brain activity and respiratory variables during sleep
DIAGNOSTIC_TESTActigraphy
monitoring daily physical activity for 7 days
DIAGNOSTIC_TESTOsler test
Evaluation of subjects´ ability to remain awake
Sponsors
AstraZeneca
Hospital Universitari Vall d'Hebron Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | One night at the sleep unit | Sleep time/Time in bed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total sleep time | One night at the sleep unit | Total sleep time |
| Arousal index | One night at the sleep unit | number of arousals/hour of sleep |
| sleep architecture | One night at the sleep unit | percentage of the different sleep phases |
| Osler test error index | Next morning after polysomnography (8a.m.--4 p.m.) | number of errors |
| Actigraphy | One week previous to polysomnography | Monitoring of rest/activity cycles |
Countries
Spain
Contacts
Primary ContactGabriel Sampol, PhD
Backup ContactJaume Ferrer, PhD
Outcome results
None listed