COPD Clinical Trial
— READ-NIVOfficial title:
Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation: READ-NIV Trial
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - hypercapnic respiratory failure (PaCO2 > 6kPa) - low usage of home mechanical ventilation (NIV < 4hours/night). - body mass index (BMI) >18.5kg/m2 - all genders - age 18-90years. Exclusion Criteria: - no hypercapnic respiratory failure (PaCO2<6kPa) - no sleep-disordered breathing (AHI<5/hour) - exclusively obstructive sleep apnoea - isolated Rapid-Eye-Movement (REM) sleep associated OSA - cachexia (BMI <18.5 kg/m2) - severe pulmonary hypertension - valvular heart disease - heart failure (New York Heart Association, NYHA III-IV) - myocardial infarction and significant cardiac arrhythmias - uncontrolled hypertension - active psychiatric disease - co-existing non-respiratory sleep disorder. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's & St Thomas' NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence | Usage / night (hours) | 3 months | |
Secondary | Epworth Sleepiness Scale | 0-24 points (higher results indicate increased levels of sleepiness) | 3 months | |
Secondary | Stanford Sleepiness Scale | 0-7 points (higher scores indicate more symptoms) | 3 months | |
Secondary | Hospital Anxiety and Depression Scale | 0-42 points (higher scores indicate more symptoms) | 3 months | |
Secondary | Severe Respiratory Insufficiency Questionnaire | points (higher scores indicate more symptoms) | 3 months | |
Secondary | EQ-5D | 0-100 points (higher scores indicate better functioning and quality of life) | 3 months | |
Secondary | Healthcare Resource Usage | contacts with GP/hospital | 3 months | |
Secondary | Arterial Blood Gas analysis | kPA | 3 months | |
Secondary | SpO2 | percentage | 3 months |
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