Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac

Intervention / Treatment
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* Drug: supplementary oxygen
* Drug: zopiclone
* Other: alcohol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 supplementary oxygen<br>participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night | Drug: supplementary oxygen<br>* Supplementary oxygen 2 L/min if SpO2 < 90%. If SpO2 < 90 % the oxygen dose is titrated until SpO2 reads 88-92%. For patients on LTOT the oxygen dose is doubled for intervention.<br>* Other names: 100% oxygen gas with continous flow from wall outlet;|
| Active Comparator: 2 Zopiclone<br>participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night | Drug: zopiclone<br>* 5 mg sedative given approximately 1 hour before sleep<br>* Other names: Imovane, Zopiklon;|
| Active Comparator: 3 Alcohol<br>participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night | Other: alcohol<br>* 5 mg alcohol/kg body-weight approximately 1 hour before sleep<br>* Other names: 96% ethanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcutaneously measured pCO2 during sleep |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac arrythmias registered by Holter monitoring |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter