Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program. A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.

Conditions
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Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation, Energy Expenditure

Intervention / Treatment
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* Device: nocturnal non-invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Intervention group: chronic obstructive pulmonary disease stage IV indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008) patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day) Exclusion Criteria for Intervention group: acute exacerbation of chronic obstructive pulmonary disease severe heart failure body-mass-index >35 m²/kg fever Inclusion Criteria for control group: chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor) Exclusion Criteria for control group: acute exacerbation of chronic obstructive pulmonary disease indication for the use of a non-invasive ventilation severe heart failure body-mass-index >35 m²/kg fever
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nocturnal non-invasive ventilation<br>patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation | Device: nocturnal non-invasive ventilation<br>* patients will undergo a non-invasive ventilation during the night<br>|
| No Intervention: no nocturnal non-invasive ventilation<br>patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy expenditure during night | energy expenditure will be assessed by Sensewear Armband | day 1-3 and day 14-16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy expenditure during day | energy expenditure will be assessed by SenseWear Armband | day 1-3 and day 14-16 | 
| lung function | measured by a bodyplethysmograph | day 1-3 and day 14-16 | 
| sleep quality | measured by Severe Respiratory Insufficiency Questionnaire | day 1-3 and day 14-16 | 
| arterial pressure of carbon dioxide during night | measured transcutaneously by a Sentec device | day 1-3 and day 14-16 | 
| movement activity during the night | night movement activity will be measured in a subgroup with the Dynaport device | day 1 |