Trials / Unknown
UnknownNCT01961245
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- Schön Klinik Berchtesgadener Land · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
- Chronic Obstructive Pulmonary Disease
- Pulmonary Rehabilitation
- Non-invasive Ventilation
- Energy Expenditure
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | nocturnal non-invasive ventilation | patients will undergo a non-invasive ventilation during the night |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2013-10-11
- Last updated
- 2019-02-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01961245. Inclusion in this directory is not an endorsement.