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

Not Applicable

Completed

• Conditions: Pulmonary Disease; Chronic Obstructive; Hypercapnia; Hypoxemia; Arrhythmias, Cardiac
• Interventions: Drug: supplementary oxygen; Other: alcohol; Drug: zopiclone

• Registration Number: NCT00888342
• Lead Sponsor: LHL Helse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 supplementary oxygen	supplementary oxygen	participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night
3 Alcohol	alcohol	participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night
2 Zopiclone	zopiclone	participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night

Primary Outcome Measures

Name	Time	Method
transcutaneously measured pCO2 during sleep	1 year

Secondary Outcome Measures

Name	Time	Method
cardiac arrythmias registered by Holter monitoring	1 year

Trial Locations

Locations (1)

Glittreklinikken; 🇳🇴 Oslo, Hakadal, Norway