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

Sponsor

LHL Helse (Other)

Overall Status

Completed

CT.gov ID

NCT00888342

Collaborator

Stiftelsen Helse og Rehabilitering (Other), Landsforeningen for hjerte og lungesyke (LHL) (Other), University Hospital, Akershus (Other), Haukeland University Hospital (Other), ResMed (Industry)

150

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease Chronic Obstructive Hypercapnia Hypoxemia Arrhythmias, Cardiac	Drug: supplementary oxygen Drug: zopiclone Other: alcohol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 96% ethanol

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

96% ethanol

Outcome Measures

Primary Outcome Measures

transcutaneously measured pCO2 during sleep [1 year]

Secondary Outcome Measures

cardiac arrythmias registered by Holter monitoring [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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