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

Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study

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.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: polysomnography; Diagnostic test: Actigraphy; Diagnostic test: Osler test

• Study Type: Observational
• Enrollment (Anticipated): 58

Contacts and Locations

• Study Contact: Name: Gabriel Sampol, PhD; Phone Number: +34932746083; Email: gsampol@vhebron.net
• Study Contact Backup: Name: Jaume Ferrer, PhD; Phone Number: +34932746083; Email: jjferrer@vhebron.net

Study Locations

• Spain
  • Barcelona, Spain, 08034
    • Recruiting
    • Hospital Universitari Vall d´Hebron
    • Contact: Gabriel Sampol, PhD; Phone Number: +34932746083; Email: gsampol@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: AstraZeneca
• Investigators: Study Chair: Marc Miravitlles, PhD, Vall d´Hebron Institut de Recerca

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): June 30, 2018
• Study Completion (ANTICIPATED): September 30, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 17, 2017
• First Posted (ACTUAL): September 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 17, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PR(AG)365/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No