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

NCT ID: NCT00888342

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-07-31

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

Conditions

Pulmonary Disease; Chronic Obstructive; Hypercapnia; Hypoxemia; Arrhythmias, Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1 supplementary oxygen

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

Group Type: ACTIVE_COMPARATOR

supplementary oxygen

Intervention Type: DRUG

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.

2 Zopiclone

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

Group Type: ACTIVE_COMPARATOR

zopiclone

Intervention Type: DRUG

5 mg sedative given approximately 1 hour before sleep

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

Group Type: ACTIVE_COMPARATOR

alcohol

Intervention Type: OTHER

5 mg alcohol/kg body-weight approximately 1 hour before sleep

Interventions

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.

Intervention Type: DRUG

zopiclone

5 mg sedative given approximately 1 hour before sleep

Intervention Type: DRUG

alcohol

5 mg alcohol/kg body-weight approximately 1 hour before sleep

Intervention Type: OTHER

Other Intervention Names

100% oxygen gas with continous flow from wall outlet; Imovane, Zopiklon; 96% ethanol

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role: collaborator

Landsforeningen for hjerte og lungesyke (LHL)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: collaborator

LHL Helse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nils H Holmedahl, MD

Role: PRINCIPAL_INVESTIGATOR

LHL Helse

Locations

Glittreklinikken

Hakadal, Akershus, Norway

Glittreklinikken

Oslo, Hakadal, Norway

Countries

Norway

Other Identifiers

2008/2/0083 (LHL)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2688 (BIOBANK)

Identifier Type: REGISTRY

Identifier Source: secondary_id

6.2009.10 (REK)

Identifier Type: REGISTRY

Identifier Source: secondary_id

GK-61

Identifier Type: -

Identifier Source: org_study_id