Monitoring of Non-invasive Ventilation During Sleep in ALS

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring of Non-invasive Ventilation During Sleep in ALS

Conditions
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Amyotrophic Lateral Sclerosis

Participation Criteria
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Eligibility Criteria
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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 symptoms of nocturnal alveolar hypoventilation or increased daytime arterial carbon dioxide partial pressure (PCO2)(> 45 mmHg) or a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value Exclusion Criteria: Patients < 18 years Patients not willing to start NIV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic Lateral Sclerosis, Noninvasive Ventilation, Polysomnography