A feasibility study comparing home-based and in-hospital methods of adjusting non-invasive ventilator settings for people with long-term breathing failure

Not Applicable

Recruiting

• Conditions: Chronic hypercapnic respiratory failure; Neuromuscular disease; Chronic obstructive lung disease (COPD); Restrictive thoracic disease; Obesity hyperventilation syndrome; Respiratory - Other respiratory disorders / diseases; Neurological - Neurodegenerative diseases; Public Health - Health service research

• Registration Number: ACTRN12623001234606
• Lead Sponsor: Institute for Breathing and Sleep, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Medically stable

With or at risk of chronic hypercapnic respiratory failure

Diagnosis of slowly progressive neuromuscular disease, chronic obstructive lung disease, chest wall disease, COPD/OSA overlap syndrome or obesity hypoventilation syndrome.

Clinical indication to commence long term NIV

Suitable for short admission to hospital for NIV implementation

Exclusion Criteria

Hypoventilation attributable to medications with sedative/respiratory depressant side-effects

Regular use of NIV (> 6 hours/day on average AND usage on >50% of days) over the previous 3 months

Geographical – lives more than 2 hours from Austin Health via road

No or inadequate support to manage home monitoring equipment or instructions to adjust therapy at home

No mobile network coverage

Home visit safety risk

Pregnancy

Non English speaking participant

Inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IV usage.[Group average daily NIV usage, averaged over four week blocks. Data will be collected directly from participants’ devices using data cards and/or the cloud-based monitoring systems (Respironics EncoreAnywhere, Resmed AirView, etc). Prior to NIV implementation, and post NIV implementation at Week 4, Week 8, Week 12, Week 16 (primary endpoint).]