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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Hypercapnia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
supplementary oxygen
zopiclone
alcohol
Sponsored by
LHL Helse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease focused on measuring Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 30, or if patient becomes acutely ill between the nights with PSG, he/she will be withdrawn from the study

Sites / Locations

  • Glittreklinikken
  • Glittreklinikken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1 supplementary oxygen

2 Zopiclone

3 Alcohol

Arm Description

participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night

participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night

participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night

Outcomes

Primary Outcome Measures

transcutaneously measured pCO2 during sleep

Secondary Outcome Measures

cardiac arrythmias registered by Holter monitoring

Full Information

First Posted
April 22, 2009
Last Updated
May 15, 2012
Sponsor
LHL Helse
Collaborators
Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), University Hospital, Akershus, Haukeland University Hospital, ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT00888342
Brief Title
Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LHL Helse
Collaborators
Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), University Hospital, Akershus, Haukeland University Hospital, ResMed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac
Keywords
Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 supplementary oxygen
Arm Type
Active Comparator
Arm Description
participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night
Arm Title
2 Zopiclone
Arm Type
Active Comparator
Arm Description
participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night
Arm Title
3 Alcohol
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
supplementary oxygen
Other Intervention Name(s)
100% oxygen gas with continous flow from wall outlet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
zopiclone
Other Intervention Name(s)
Imovane, Zopiklon
Intervention Description
5 mg sedative given approximately 1 hour before sleep
Intervention Type
Other
Intervention Name(s)
alcohol
Other Intervention Name(s)
96% ethanol
Intervention Description
5 mg alcohol/kg body-weight approximately 1 hour before sleep
Primary Outcome Measure Information:
Title
transcutaneously measured pCO2 during sleep
Time Frame
1 year
Secondary Outcome Measure Information:
Title
cardiac arrythmias registered by Holter monitoring
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils H Holmedahl, MD
Organizational Affiliation
LHL Helse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glittreklinikken
City
Hakadal
State/Province
Akershus
ZIP/Postal Code
1485
Country
Norway
Facility Name
Glittreklinikken
City
Oslo
State/Province
Hakadal
ZIP/Postal Code
1485
Country
Norway

12. IPD Sharing Statement

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

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