Clinical trial NCT00888342: Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients
Official title: A Study of Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in Patients With COPD in Different Stages of the Disease, and the Effect of Alcohol, Supplementary Oxygen and Zopiclone on These Changes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Chronic Obstructive
Hypercapnia
Hypoxemia
Arrhythmias, Cardiac
Keywords: Pulmonary Disease
Chronic Obstructive
Hypercapnia
Hypoxemia
Arrhythmias, Cardiac
Polysomnography
Capnography
Electrocardiography, Holter
Lead sponsor: LHL Helse
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: Landsforeningen for hjerte og lungesyke (LHL)
name: University Hospital, Akershus
name: Haukeland University Hospital
name: ResMed
First posted: 2009-04-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Respiration failure type 2 is loss of the lungs ability to take up oxygen (O2) and get rid of carbon dioxide (CO2). The diagnosis is based on blood gas measurement of pressures of O2 and CO2. Patients with COPD is often seen to have co-morbidity with cardiac diseases. Chronic systemic inflammation is seen in both COPD and cardiac diseases. The investigators will investigate the sleep quality, CO2-retention, O2-saturation, cardiac arrythmias and markers of inflammation in 120 patients with COPD in different stages of the disease. Our hypotheses are:

* that the first signs of respiration failure type 2 is seen during sleep with alteration of sleep patterns and greater and more long-lasting retention of CO2 in the blood compared to those with a normal lung function
* that the use of alcohol, zopiclone or supplementary oxygen will make these differences even greater
* that cardiac arrythmias correlates with hypoxemia
* that cardiac arrythmias and respiration failure correlates with degree of inflammation


Eligibility criteria: Inclusion Criteria:

* COPD (FEV1 \< 80 % of pred. and FEV1/FVC \< 0,7)

Exclusion Criteria:

* other serious disease (like lung cancer, sarcoidosis, restrictive lung disease)
* exacerbation of COPD within 3 weeks before inclusion
* coronary heart disease with unstable angina pectoris or myocardial infarction within 3 months of incl.
* uncontrolled hypertension
* cerebral infarction
* neurological, muscular or skeletal disease/disorder that affect abdominal- and/or thoracal movements (kyphoscoliosis, paresis, etc)
* unstable diabetes mellitus or signs of organ failure (anaemia, kidney failure, liver failure, etc)
* misuse/dependency of alcohol, sedatives, neurostimulating or narcotic drugs)
* obstructive sleep apnoea/hypopnoea syndrome
* using CPAP/BiPAP or home respirator
* pregnancy
* if PSG shows AHI \> 30, or if patient becomes acutely ill between the nights with PSG, he/she will be withdrawn from the study

Primary outcomes:
measure: transcutaneously measured pCO2 during sleep
timeFrame: 1 year
Secondary outcomes:
measure: cardiac arrythmias registered by Holter monitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
state: Akershus
city: Oslo
country: Norway
facility: Glittreklinikken
state: Hakadal
Study officials:
affiliation: LHL Helse
name: Nils H Holmedahl, MD
role: PRINCIPAL_INVESTIGATOR
References: