Monitoring of Non-invasive Ventilation During Sleep in ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01889043|
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : December 14, 2015
Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.
Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.
|Condition or disease|
|Amyotrophic Lateral Sclerosis|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Monitoring of Non-invasive Ventilation During Sleep in ALS|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2015|
- Change in transcutaneous carbon dioxide and respiratory events [ Time Frame: At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months ]Search for an optimal titration protocol. Aim is to reduce transcutaneous carbon dioxide (CO2) below 55 mmHg and to reduce central and obstructive respiratory events to a minimum. This will be assessed by performance of a nocturnal measurement of transcutaneous CO2 and full polysomnography at eacht time point.
- Change in patient-ventilator asynchronies [ Time Frame: Day 4 and at 1,3,6,9 and 12 months ]The following asynchronies will be evaluated: auto-triggering, double triggering, ineffective effort, prolonged insufflation. The impact of leaks will also be evaluated.Data will be reported as events/hour of sleep. This will be assessed by full polysomnography at each time point.
- Impact of NIV on sympatho-vagal balance [ Time Frame: Day 1 and at 1,3,6,9 and 12 months ]
- changes in quality of life by patient reported outcomes [ Time Frame: Day 1 and at 1,3,6,9 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889043
|Leuven, Belgium, 3000|
|Principal Investigator:||Dries Testelmans, MD,PhD||UZ Leuven|
|Study Director:||Bertien Buyse, MD, PhD||UZ Leuven|