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.

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

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Pulmonary Disease; Hypoxemia; Hypercapnia; Chronic Obstructive
• Intervention / Treatment: Drug: supplementary oxygen; Drug: zopiclone; Other: alcohol

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Hakadal, Akershus, Norway, 1485
      • Glittreklinikken
  • Hakadal
    • Oslo, Hakadal, Norway, 1485
      • Glittreklinikken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1 supplementary oxygen; participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night	Drug: supplementary 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.; Other Names: 100% oxygen gas with continous flow from wall outlet
ACTIVE_COMPARATOR: 2 Zopiclone; participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night	Drug: zopiclone; 5 mg sedative given approximately 1 hour before sleep; Other Names: Imovane, Zopiklon
ACTIVE_COMPARATOR: 3 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	Other: alcohol; 5 mg alcohol/kg body-weight approximately 1 hour before sleep; Other Names: 96% ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
transcutaneously measured pCO2 during sleep	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LHL Helse
• Collaborators: ResMed; Haukeland University Hospital; University Hospital, Akershus; Stiftelsen Helse og Rehabilitering; Landsforeningen for hjerte og lungesyke (LHL)
• Investigators: Principal Investigator: Nils H Holmedahl, MD, LHL Helse

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (ESTIMATE): April 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Polysomnography; Hypercapnia; Pulmonary Disease; Capnography; Arrhythmias, Cardiac; Hypoxemia; Chronic Obstructive; Electrocardiography, Holter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lung Diseases; Arrhythmias, Cardiac; Hypoxia; Hypercapnia; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Hypnotics and Sedatives; Ethanol; Zopiclone
• Other Study ID Numbers: GK-61; 2008/2/0083 (LHL) (OTHER_GRANT: Landsforeningen for Hjerte og Lungesyke (LHL)); 2688 (BIOBANK) (REGISTRY: The National Committees for Research Ethics in Norway); 6.2009.10 (REK) (REGISTRY: The National Committees for Research Ethics in Norway)