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

Not Applicable

• Conditions: Pulmonary Rehabilitation; Non-invasive Ventilation; Energy Expenditure; Chronic Obstructive Pulmonary Disease
• Interventions: Device: nocturnal non-invasive ventilation

• Registration Number: NCT01961245
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Study Start: 2013-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nocturnal non-invasive ventilation	nocturnal non-invasive ventilation	patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation

Primary Outcome Measures

Name	Time	Method
energy expenditure during night	day 1-3 and day 14-16	energy expenditure will be assessed by Sensewear Armband

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schoenau Am Koenigssee, Bavaria, Germany