Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients
This study has been completed.
Sponsor:
LHL Helse
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
| Tracking Information | |||||
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| First Received Date ICMJE | April 22, 2009 | ||||
| Last Updated Date | May 15, 2012 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
transcutaneously measured pCO2 during sleep [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00888342 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
cardiac arrythmias registered by Holter monitoring [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients | ||||
| Official Title ICMJE | 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. | ||||
| 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:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00888342 | ||||
| Other Study ID Numbers ICMJE | GK-61, 2008/2/0083 (LHL), 2688 (BIOBANK), 6.2009.10 (REK) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | LHL Helse | ||||
| Study Sponsor ICMJE | LHL Helse | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | LHL Helse | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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