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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Good sleepers | COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test |
| |
| Bad sleepers | COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnography | Diagnostic Test | Monitoring of brain activity and respiratory variables during sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | Sleep time/Time in bed | One night at the sleep unit |
| 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 |
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Inclusion criteria:
Patients with written inform consent to participate in the study and all the following criteria will be selected:
Exclusion criteria:
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Consecutive patients aged 40-80 years, smokers or exsmokers of at least 10 pack-years, diagnosed with moderate-to-severe COPD (post bronchodilator FEV1% < 70% and FEV1 ≥ 30 but < 80% of predicted in a spirometry performed within 6 months prior to inclusion into the study)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Sampol, PhD | Contact | +34932746083 | gsampol@vhebron.net | |
| Jaume Ferrer, PhD | Contact | +34932746083 | jjferrer@vhebron.net |
| Name | Affiliation | Role |
|---|---|---|
| Marc Miravitlles, PhD | Vall d´Hebron Institut de Recerca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d´Hebron | Recruiting | Barcelona | 08034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19968881 | Background | 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. | |
| 23037958 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2016 | Sep 12, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| D056044 | Actigraphy |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061725 | Accelerometry |
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| Actigraphy | Diagnostic Test | monitoring daily physical activity for 7 days |
|
| Osler test | Diagnostic Test | Evaluation of subjects´ ability to remain awake |
|
|
| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 |
| Investigative Techniques |