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

This study has been completed.
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Landsforeningen for hjerte og lungesyke (LHL)
University Hospital, Akershus
Haukeland University Hospital
ResMed
Information provided by (Responsible Party):
LHL Helse
ClinicalTrials.gov Identifier:
NCT00888342
First received: April 22, 2009
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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

Condition Intervention
Pulmonary Disease
Chronic Obstructive
Hypercapnia
Hypoxemia
Arrhythmias, Cardiac
 Drug: supplementary oxygen
Drug: zopiclone
Other: alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LHL Helse:

Primary Outcome Measures:
  • transcutaneously measured pCO2 during sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiac arrythmias registered by Holter monitoring [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 96% ethanol

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888342

Locations
Norway
Glittreklinikken
Hakadal, Akershus, Norway, 1485
Glittreklinikken
Oslo, Hakadal, Norway, 1485
Sponsors and Collaborators
LHL Helse
Stiftelsen Helse og Rehabilitering
Landsforeningen for hjerte og lungesyke (LHL)
University Hospital, Akershus
Haukeland University Hospital
ResMed
Investigators
Principal Investigator: Nils H Holmedahl, MD LHL Helse
  More Information

No publications provided

Responsible Party: LHL Helse
ClinicalTrials.gov Identifier: NCT00888342     History of Changes
Other Study ID Numbers: GK-61, 2008/2/0083 (LHL), 2688 (BIOBANK), 6.2009.10 (REK)
Study First Received: April 22, 2009
Last Updated: May 15, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Institute of Public Health
Norway: Directorate of Health

Keywords provided by LHL Helse:
Pulmonary Disease
Chronic Obstructive
Hypercapnia
Hypoxemia
 Arrhythmias, Cardiac
Polysomnography
Capnography
Electrocardiography, Holter

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Hypercapnia
Lung Diseases
Respiration Disorders
Anoxia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Diseases
 Ethanol
Zopiclone
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 21, 2013