Approaching the Non Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS) at home: a Randomized Controlled Trial

Background: Respiratory failure is one of the most common causes of death in ALS patients. Treatment of ALS patients with NIV when FVC<80% appears to improve their survival and quality of life. NIV implementation generally occurred during inpatient admission, and the high demand is increasing waiting times. Aims and objectives: In ALS patients we evaluated if domiciliary initiation (HP) to NIV is effective as outpatient initiation (OP) in terms of arterial blood gas analysis, pulmonary function test and quality of life. Methods: Patients were randomized in two groups (HP vs OP). Diurnal adaptation, advice to use nocturnal NIV until adaptation (<6 hours/night for 3 nights) were conducted in OP as well as in HP with at least 4 hours of monitoring. 5-weeks educational sessions at home vs. ambulatory with two months follow-up were provided. Results: Forty-one patients (18 males) participated to the study being similar in terms of ALS score, age, body mass index. After the initiation EtCO2, SpO2, PaCO2 were improved in both groups. Respiratory functions, symptoms and sleep quality were similar between groups. Quality of life was not significantly different between groups (p=.528). However, caregiver’s burden was significantly improved in the HP group (p=.002). Conclusions: HP initiation to NIV in ALS is as effective as OP initiation.