Remote monitoring to improve low adherence in non-invasive ventilation: a protocol for a randomised controlled clinical trial (READ-NIV trial).

BACKGROUND: Obstructive sleep apnoea (OSA) is the most common sleep-related breathing disorder. Non-invasive ventilation (NIV) is essential for managing hypercapnic respiratory failure in patients with obesity hypoventilation syndrome (OHS) and those with co-existing OSA, where continuous positive airway pressure (CPAP) alone is insufficient. However, adherence to NIV can be challenging, with substantial non-compliance occurring due to factors such as discomfort and phobia. The objective of this protocol is to assess the improvement of adherence to NIV remotely monitored, as well as to record symptom control and long-term clinical outcomes, and to optimise healthcare resource usage.

METHODS: This is a prospective, randomised, and controlled (usual care) trial with a two-arm parallel group design, testing remote monitoring of home NIV (T4P device, SRETT, Paris, France) for 3 months in patients with OSA/OHS who have previously had low NIV adherence (<4 hours/night). This project has been approved by the research ethics committee/Health Research Authority (HRA) [Integrated Research Application System (IRAS) ID: 270108], as well as by Guy's & St Thomas' NHS Foundation Trust R&D Department.

DISCUSSION: Outcomes will be compared between the intervention and the control group (NIV with vs. without remote monitoring). The trial will also assess suitability of the outcome parameters, and test whether the data collection, symptom questionnaires, and used healthcare resources are suitable to describe the impact on patient-related outcomes.

TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT04884165).