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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in transcutaneous carbon dioxide and respiratory events | 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. | At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months |
| Change in patient-ventilator asynchronies | 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. | Day 4 and at 1,3,6,9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of NIV on sympatho-vagal balance | Day 1 and at 1,3,6,9 and 12 months | |
| changes in quality of life by patient reported outcomes | Day 1 and at 1,3,6,9 and 12 months |
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Inclusion Criteria:
Patients with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and
Exclusion Criteria:
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Amyotrophic lateral sclerosis patients, which are followed at the Neuromuscular Reference Centre UZ Leuven, in need for NIV treatment
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| Name | Affiliation | Role |
|---|---|---|
| Dries Testelmans, MD,PhD | UZ Leuven | Principal Investigator |
| Bertien Buyse, MD, PhD | UZ Leuven | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |