Pulmonary DiseaseNCT00888342
Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients
A study testing supplementary oxygen, zopiclone and alcohol in people with Pulmonary Disease and Chronic Obstructive, run by LHL Helse at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
- What is being tested?
- supplementary oxygen, zopiclone and alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesNorway
- Study dates
- May 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD (FEV1 < 80 % of pred. and FEV1/FVC < 0,7)
Who cannot join
- 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)
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- 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 30, or if patient becomes acutely ill between the nights with PSG, he/she will be withdrawn from the study
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Glittreklinikken
Hakadal, Akershus, 1485
Glittreklinikken
Oslo, Hakadal, 1485
About this study
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.
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
- Being tested
- supplementary oxygen, zopiclone, alcohol
- Keywords
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter
- Medical subject headings
- Lung Diseases, Hypercapnia, Hypoxia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementary oxygenDrug
Also called 100% oxygen gas with continous flow from wall outlet
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.
zopicloneDrug
Also called Imovane, Zopiklon
5 mg sedative given approximately 1 hour before sleep
alcoholOther
Also called 96% ethanol
5 mg alcohol/kg body-weight approximately 1 hour before sleep
| Study group | Role | What they receive |
|---|---|---|
| 1 supplementary oxygen | Active comparator | participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night Receives: Drug: supplementary oxygen |
| 2 Zopiclone | Active comparator | participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night Receives: Drug: zopiclone |
| 3 Alcohol | Active comparator | participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night Receives: Other: alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
transcutaneously measured pCO2 during sleep
Measured: 1 year
Secondary outcomes (1)
cardiac arrythmias registered by Holter monitoring
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), University Hospital, Akershus, Haukeland University Hospital, ResMed
- Responsible party
- Sponsor
- Investigators
- Nils H Holmedahl, MD, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888342
- Sponsor's protocol ID
- GK-61
- Other IDs
- 2008/2/0083 (LHL), 2688 (BIOBANK), 6.2009.10 (REK)
- Status last verified
- May 2012
- First submitted
- 22 Apr 2009
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00888342
- Acronym / sponsor ID
- GK-61
- Keywords
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxemia, Arrhythmias, Cardiac, Polysomnography, Capnography, Electrocardiography, Holter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering, Landsforeningen for hjerte og lungesyke (LHL), University Hospital, Akershus, Haukeland University Hospital, ResMed
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 supplementary oxygen | Active comparator | Drug: supplementary oxygenparticipant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night |
| 2 Zopiclone | Active comparator | Drug: zopicloneparticipant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night |
| 3 Alcohol | Active comparator | Other: alcoholparticipant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COPD (FEV1 < 80 % of pred. and FEV1/FVC < 0,7)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementary oxygenAlso: 100% oxygen gas with continous flow from wall outletSupplementary 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. | Drug | 1 supplementary oxygen |
| zopicloneAlso: Imovane, Zopiklon5 mg sedative given approximately 1 hour before sleep | Drug | 2 Zopiclone |
| alcoholAlso: 96% ethanol5 mg alcohol/kg body-weight approximately 1 hour before sleep | Other | 3 Alcohol |
Primary outcome
transcutaneously measured pCO2 during sleep
Time frame: 1 year
1 secondary outcome
cardiac arrythmias registered by Holter monitoring
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils H Holmedahl, MD principal investigator
LHL Helse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementary oxygen, zopiclone and alcohol in people with Pulmonary Disease and Chronic Obstructive, run by LHL Helse at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transcutaneously measured pCO2 during sleep (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.