Clinical trial NCT03290014: Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)
Official title: Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2017-09-21
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep efficiency
timeFrame: One night at the sleep unit
Secondary outcomes:
measure: Total sleep time
timeFrame: One night at the sleep unit
measure: Arousal index
timeFrame: One night at the sleep unit
measure: sleep architecture
timeFrame: One night at the sleep unit
measure: Osler test error index
timeFrame: Next morning after polysomnography (8a.m.--4 p.m.)
measure: Actigraphy
timeFrame: One week previous to polysomnography
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
Study officials:
affiliation: Vall d´Hebron Institut de Recerca
name: Marc Miravitlles, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.