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NCT Number: NCT00888342

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

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

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Key information

Conditions

Pulmonary Disease Arrhythmias, Cardiac Cardiovascular Diseases Chronic Obstructive Heart Diseases Hypercapnia Hypoxemia Hypoxia Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glittreklinikken, Hakadal, Akershus, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supplementary oxygen

Drug

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

Zopiclone

Drug

5 mg sedative given approximately 1 hour before sleep

Other names: Imovane, Zopiklon

Alcohol

Other

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

Other names: 96% ethanol

Primary outcomes

  1. transcutaneously measured pCO2 during sleep

    Time frame: 1 year

Secondary outcomes

  1. cardiac arrythmias registered by Holter monitoring

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

LHL Helse

Other

Collaborators

  • Haukeland University Hospital
  • Landsforeningen for hjerte og lungesyke (LHL)
  • ResMed
  • Stiftelsen Helse og Rehabilitering
  • University Hospital, Akershus

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2009
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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