READ-NIV trial
Research type
Research Study
Full title
Remote monitoring to improve low adherence in non-invasive ventilation: READ-NIV trial
IRAS ID
270108
Contact name
Joerg Steier
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, READ-NIV 15-11-2020 V1.0 (awaiting approval)
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treated using home mechanical ventilation, also called non-invasive ventilation (NIV). Breathing difficulties during sleep affect many patients with conditions such as chronic pulmonary obstructive disease (COPD), neuromuscular conditions and obesity hypoventilation syndrome. Left untreated they can cause breathlessness, headaches, sleepiness and lead to hospitalisations and other severe adverse health outcomes.
The best available treatment for chronic types of sleep-disordered breathing is NIV. However, not everyone eligible tolerates this treatment because it requires patients to sleep with a nasal or full-face mask that is connected with a tube to a machine. Although NIV is recommended by the National Institute for Health and Clinical Excellence (NICE), many patients who should be on NIV use the treatment insufficiently within months.
Using remote monitoring to identify problems with treatment adherence early on may help to identify clinical problems, troubleshoot user- or device-dependent problems, avoid delays in treatment and safe healthcare resources in the long-term.
We invite patients who use NIV to participate in this trial when they have difficulties with the treatment (NIV). This study will evaluate compliance and efficacy of a remote monitoring device (T4P device, SRETT, Paris/France) that will be connected to the standard NIV machine to remotely monitor usage. Patients will be randomly assigned to the remote monitoring using NIV for three months at home, or to usual care which is NIV without this monitoring. The primary outcome measure of this study is the improvement in adherence and compliance, as indicated by the average usage of NIV, as well as symptom scores to assess treatment effects.
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0089
Date of REC Opinion
6 Apr 2021
REC opinion
Further Information Favourable Opinion