Table 1 Inclusion and exclusion criteria

Age 20 to 75 years

Psychiatric disease or other neurological disease different from ALS

Non ambulatory (walking subscore 0–1 of the ALS-FRS-R scale)

Evidence of any concurrent illness

Evidence of progression disease in the last six months

Patients receiving corticosteroids, immunoglobulin or immunosuppressive treatment**

Absence of sleep apneas or hypopneas with blood oxygen saturation lower than 90%,*

Mental deterioration or cognitive sphere disturbance

FVC higher than 60%

Non-invasive ventilation (NIV) >6 hours daily Patients unable to understand informed consent form and study aims

Supposed good adherence to study protocol

Women who were pregnant or childbearing potential for the duration of the study.

Good acceptance and understanding of the informed consent