Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial

Background: Initiation to Non-Invasive Ventilation (NIV) in amyotrophic lateral sclerosis\r\n(ALS) can be implemented in an inpatient or outpatient setting. Aims: We aimed to evaluate the\r\nefficacy of adaptation (the number of needed sessions) to home-based NIV compared to an outpatient\r\none in ALS in terms of arterial carbon dioxide (PaCO2) improvement. NIV acceptance (mean use of ≥5\r\nh NIV per night for three consecutive nights during the adaptation trial), adherence (night-time NIV\r\nusage for ≥150 h/month), quality of life (QoL), and caregiver burden were secondary outcomes.\r\nMethods: A total of 66 ALS patients with indications for NIV were involved in this randomized\r\ncontrolled trial (RCT): 34 underwent NIV initiation at home (home adaptation, HA) and 32 at multiple\r\noutpatient visits (outpatient adaptation, OA). Respiratory function tests were performed at baseline\r\n(the time of starting the NIV, T0) together with blood gas analysis, which was repeated at the end of\r\nadaptation (T1) and 2 (T2) and 6 (T3) months after T1. NIV adherence was measured at T2 and T3.\r\nOvernight cardiorespiratory polygraphy, Short Form Health Survey (SF-36), Caregiver Burden\r\nInventory (CBI), Caregiver Burden Scale (CBS), and Zarit Burden Interview (ZBI) were performed at\r\nT0, T2, and T3. Results: Fifty-eight participants completed the study. No differences were found\r\nbetween groups in PaCO2 at T1 (p = 0.46), T2 (p = 0.50), and T3 (p = 0.34) in acceptance (p = 0.55) and\r\nadherence to NIV at T2 and T3 (p = 0.60 and p = 0.75, respectively). At T2, the patients’ QoL, assessed\r\nwith SF-36, was significantly better in HA than in OA (p = 0.01), but this improvement was not\r\nmaintained until T3 (p = 0.17). Conclusions: In ALS, adaptation to NIV in the patient’s home is as\r\neffective as that performed in an outpatient setting regarding PaCO2, acceptance, and adherence,\r\nwhich emphasizes the need for further studies to understand the role of the environment concerning\r\nNIV adherence.