NCT04884165: READ-NIV

Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation

Completed NA Last updated 18 June 2024

What this trial tests

NA trial testing Remote monitoring of home mechanical ventilation (NIV) using SRETT in Hypercapnic Respiratory Failure in 32 participants. Completed in 12 June 2024.

Timeline

28 March 2022

Primary endpoint
12 June 2024

12 June 2024

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	28 March 2022
Primary completion	12 June 2024
Estimated completion	12 June 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Remote monitoring of home mechanical ventilation (NIV) using SRETT
• Home mechanical ventilation (NIV) without remote monitoring

Conditions studied

• Hypercapnic Respiratory Failure — all drugs for Hypercapnic Respiratory Failure →
• Sleep Disordered Breathing — all drugs for Sleep Disordered Breathing →
• COPD — all drugs for COPD →
• Obesity Hypoventilation Syndrome (OHS) — all drugs for Obesity Hypoventilation Syndrome (OHS) →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

Adults 18 to 90, any sex, with Hypercapnic Respiratory Failure or Sleep Disordered Breathing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 every patient 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.

The investigators 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond the Brain: Exploring the multi-organ axes in Parkinson's disease pathogenesis.
   Liu T, Wu H, Wei J. · · 2026 · cited 9× · PMID 40383292 · DOI 10.1016/j.jare.2025.05.034
2. Remote monitoring to improve low adherence in non-invasive ventilation: a protocol for a randomised controlled clinical trial (READ-NIV trial).
   Alsharifi A, Kaltsakas G, Ramsay M, Owusu-Afriyie J, et al · · 2024 · PMID 39444901 · DOI 10.21037/jtd-24-86