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

April 22, 2009
May 15, 2012
May 2009
July 2011   (final data collection date for primary outcome measure)
transcutaneously measured pCO2 during sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00888342 on ClinicalTrials.gov Archive Site
cardiac arrythmias registered by Holter monitoring [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Pulmonary Disease
  • Chronic Obstructive
  • Hypercapnia
  • Hypoxemia
  • Arrhythmias, Cardiac
  • 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
  • Drug: zopiclone
    5 mg sedative given approximately 1 hour before sleep
    Other Name: Imovane, Zopiklon
  • Other: alcohol
    5 mg alcohol/kg body-weight approximately 1 hour before sleep
    Other Name: 96% ethanol
  • Active Comparator: 1 supplementary oxygen
    participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night
    Intervention: Drug: supplementary oxygen
  • Active Comparator: 2 Zopiclone
    participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night
    Intervention: Drug: zopiclone
  • 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
    Intervention: Other: alcohol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00888342
GK-61, 2008/2/0083 (LHL), 2688 (BIOBANK), 6.2009.10 (REK)
No
LHL Helse
LHL Helse
  • Stiftelsen Helse og Rehabilitering
  • Landsforeningen for hjerte og lungesyke (LHL)
  • University Hospital, Akershus
  • Haukeland University Hospital
  • ResMed
Principal Investigator: Nils H Holmedahl, MD LHL Helse
LHL Helse
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP