Monitoring of Non-invasive Ventilation During Sleep in ALS

Universitaire Ziekenhuizen KU Leuven40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 1. symptoms of nocturnal alveolar hypoventilation or 2. increased daytime arterial carbon dioxide partial pressure (PCO2)(\> 45 mmHg) or 3. 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

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day 4 and at 1,3,6,9 and 12 months

Secondary Outcomes

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