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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888342

Enrollment

150

Registered

2009-04-27

Start date

2009-05-31

Completion date

2011-07-31

Last updated

2012-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter

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

Interventions

DRUGsupplementary oxygen

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.

DRUGzopiclone

5 mg sedative given approximately 1 hour before sleep

OTHERalcohol

5 mg alcohol/kg body-weight approximately 1 hour before sleep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
transcutaneously measured pCO2 during sleep	1 year

Secondary

Measure	Time frame
cardiac arrythmias registered by Holter monitoring	1 year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026