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

COPD Clinical Trial

— COPD  

Official title:

Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290014
• Other study ID #: PR(AG)365/2015
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2017
• Last updated: September 17, 2017
• Start date: March 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Gabriel Sampol, PhD
• Phone: +34932746083
• Email: gsampol[@]vhebron.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• polysomnography
Monitoring of brain activity and respiratory variables during sleep
• Actigraphy
monitoring daily physical activity for 7 days
• Osler test
Evaluation of subjects´ ability to remain awake

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d´Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	AstraZeneca

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	Sleep time/Time in bed	One night at the sleep unit
Secondary	Total sleep time	Total sleep time	One night at the sleep unit
Secondary	Arousal index	number of arousals/hour of sleep	One night at the sleep unit
Secondary	sleep architecture	percentage of the different sleep phases	One night at the sleep unit
Secondary	Osler test error index	number of errors	Next morning after polysomnography (8a.m.--4 p.m.)
Secondary	Actigraphy	Monitoring of rest/activity cycles	One week previous to polysomnography