Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation

NCT04884165 | Completed

• 2 other identifiers: READ-NIV 15-11-2020 V1.0270108
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypercapnic Respiratory Failure; Sleep Disordered Breathing; COPD; Obesity Hypoventilation Syndrome (OHS)

Keywords

Non-invasive ventilation; Home mechanical ventilation; Remote monitoring; Adherence; Compliance

Outcome Measures

Primary Outcomes (1)

• Adherence

  Usage / night (hours)

  3 months

Secondary Outcomes (8)

• Epworth Sleepiness Scale

  3 months

• Stanford Sleepiness Scale

  3 months

• Hospital Anxiety and Depression Scale

  3 months

• Severe Respiratory Insufficiency Questionnaire

  3 months

• EQ-5D

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Remote monitoring using SRETT (CE marked device) + home mechanical ventilation (non-invasive ventilation, NIV) and usual care.

Device: Remote monitoring of home mechanical ventilation (NIV) using SRETT

Control

ACTIVE COMPARATOR

Home mechanical ventilation (non-invasive ventilation, NIV) with usual care.

Other: Home mechanical ventilation (NIV) without remote monitoring

Interventions

Remote monitoring of home mechanical ventilation (NIV) using SRETT DEVICE

Patients will use the SRETT device attached to their home ventilator.

Intervention

Home mechanical ventilation (NIV) without remote monitoring OTHER

Usual care

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Alsharifi A, Kaltsakas G, Ramsay M, Owusu-Afriyie J, Radcliffe G, Rafferty G, Steier J. Remote monitoring to improve low adherence in non-invasive ventilation: a protocol for a randomised controlled clinical trial (READ-NIV trial). J Thorac Dis. 2024 Sep 30;16(9):6263-6271. doi: 10.21037/jtd-24-86. Epub 2024 Sep 4.

  PMID: 39444901 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Sleep Apnea Syndromes; Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Patient Compliance

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Hypoventilation; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Joerg Steier, PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, parallel group controlled, unblinded clinical trial

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: March 28, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: within one year following completion of the trial
• Access Criteria: upon request

Locations

GB (1)