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Clinical Trials/NCT01961245
NCT01961245UnknownNot Applicable

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

Schön Klinik Berchtesgadener Land2 sites in 1 country85 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
85
Locations
2
Primary Endpoint
energy expenditure during night

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

no nocturnal non-invasive ventilation

No Intervention

patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation

nocturnal non-invasive ventilation

Active Comparator

patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation

Intervention: nocturnal non-invasive ventilation (Device)

Outcomes

Primary Outcomes

energy expenditure during night

Time Frame: day 1-3 and day 14-16

energy expenditure will be assessed by Sensewear Armband

Secondary Outcomes

  • energy expenditure during day(day 1-3 and day 14-16)
  • movement activity during the night(day 1)
  • lung function(day 1-3 and day 14-16)
  • sleep quality(day 1-3 and day 14-16)
  • arterial pressure of carbon dioxide during night(day 1-3 and day 14-16)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Klaus Kenn

Dr.

Schön Klinik Berchtesgadener Land

Study Sites (2)

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