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

NCT03290014 | Unknown

• 1 other identifier: PR(AG)365/2015
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency

  Sleep time/Time in bed

  One night at the sleep unit

Secondary Outcomes (5)

• Total sleep time

  One night at the sleep unit

• Arousal index

  One night at the sleep unit

• sleep architecture

  One night at the sleep unit

• Osler test error index

  Next morning after polysomnography (8a.m.--4 p.m.)

• Actigraphy

  One week previous to polysomnography

Study Arms (2)

Good sleepers

COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test

Diagnostic Test: polysomnography; Diagnostic Test: Actigraphy; Diagnostic Test: Osler 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; Diagnostic Test: Actigraphy; Diagnostic Test: Osler test

Interventions

polysomnography DIAGNOSTIC_TEST

Monitoring of brain activity and respiratory variables during sleep

Bad sleepers; Good sleepers

Actigraphy DIAGNOSTIC_TEST

monitoring daily physical activity for 7 days

Bad sleepers; Good sleepers

Osler test DIAGNOSTIC_TEST

Evaluation of subjects´ ability to remain awake

Also known as: Oxford sleep resistance test

Bad sleepers; Good sleepers

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• AstraZeneca: collaborator

Study Sites (1)

Hospital Universitari Vall d´Hebron

Barcelona, 08034, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 19968881 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.

  PMID: 23037958 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Polysomnography; Actigraphy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Marc Miravitlles, PhD

  Vall d´Hebron Institut de Recerca

  STUDY CHAIR

Central Study Contacts

Gabriel Sampol, PhD

CONTACT

+34932746083; gsampol@vhebron.net

Jaume Ferrer, PhD

CONTACT

+34932746083; jjferrer@vhebron.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 21, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 21, 2017

Record last verified: 2017-09

Locations

ES (1)