NCT00888342

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

April 22, 2009

Last Update Submit

May 15, 2012

Conditions

Pulmonary DiseaseChronic ObstructiveHypercapniaHypoxemiaArrhythmias, Cardiac

Keywords

Pulmonary DiseaseChronic ObstructiveHypercapniaHypoxemiaArrhythmias, CardiacPolysomnographyCapnographyElectrocardiography, Holter

Outcome Measures

Primary Outcomes (1)

  • transcutaneously measured pCO2 during sleep

    1 year

Secondary Outcomes (1)

  • cardiac arrythmias registered by Holter monitoring

    1 year

Study Arms (3)

1 supplementary oxygen

ACTIVE COMPARATOR

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

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

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

Other: alcohol

Interventions

supplementary oxygenDRUG

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.

Also known as: 100% oxygen gas with continous flow from wall outlet
1 supplementary oxygen
zopicloneDRUG

5 mg sedative given approximately 1 hour before sleep

Also known as: Imovane, Zopiklon
2 Zopiclone
alcoholOTHER

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

Also known as: 96% ethanol
3 Alcohol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • COPD (FEV1 \< 80 % of pred. and FEV1/FVC \< 0,7)

You may not qualify if:

  • other serious disease (like lung cancer, sarcoidosis, restrictive lung disease)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glittreklinikken

Hakadal, Akershus, 1485, Norway

Location

Glittreklinikken

Oslo, Hakadal, 1485, Norway

Location

MeSH Terms

Conditions

Lung DiseasesHypercapniaHypoxiaArrhythmias, Cardiac

Interventions

zopicloneEthanol

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Nils H Holmedahl, MD

    LHL Helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 27, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

NO(2)