None listed
Conditions
Brief summary
Non-invasive ventilation (NIV) is a treatment that uses positive pressure delivered via a face or mouthpiece to assist a person to breathe. It can be used as a long-term treatment for people whose breathing has failed – usually due to chronic conditions that produce weakness of the respiratory muscles (i.e. motor neurone disease [MND] or muscular dystrophy), restriction of chest wall movement (i.e. severe obesity or kyphoscoliosis) or in those with severe loss of lung function (i.e. from emphysema or cystic fibrosis). Most people use this treatment at night to improve their breathing during sleep. If a person is unable to use NIV they can be admitted to hospital overnight to undergo a polysomnography (PSG, “sleep study”) in order to adjust ventilator settings and use NIV more effectively. Previous studies have shown that home-based sleep studies or polygraphies, are both safe and feasible, however it is not known whether patient ventilator synchrony can be optimized similarly to a hospital-based PSG. This study will compare the current hospital admission-based model for adjustment of NIV, with two different home-based models for adjusting NIV therapy, with the goals to improve usage and access to this life sustaining treatment for a vulnerable population. Successful model development will likely also reduce use of acute hospital beds and thus costs.
Interventions
Patients will be randomised to one of three arms prior to NIV implementation, and will remain in the study arm they were allocated to for the duration of the trial. There is a four-week acclimatisation period (Time 0 to Week 4), a four-week intervention period (Week 4 to Week 8), and an eight-week follow-up period (Week 8 to Week 16). NIV usage is recorded by the NIV device. After an acclimatisation period (4 weeks), only participants who are not successfully using NIV will be provided with the
Patients will be randomised to one of three arms prior to NIV implementation, and will remain in the study arm they were allocated to for the duration of the trial. There is a four-week acclimatisation period (Time 0 to Week 4), a four-week intervention period (Week 4 to Week 8), and an eight-week follow-up period (Week 8 to Week 16). NIV usage is recorded by the NIV device. After an acclimatisation period (4 weeks), only participants who are not successfully using NIV will be provided with the once off overnight sleep study assessment and NIV adjustments corresponding to their study arm. Participants will be asked to continue to use NIV as prescribed for the subsequent follow up period. Participants may undergo their NIV monitoring more than once, if deemed necessary by the clinician, to improve NIV treatment. Experimental 1: Intervention In the ‘Experimental 1’ arm participants will receive adjustments to NIV settings based off ‘Breath by breath’ analysis of a polygraphy conducted at home. This arm involves a physiotherapist or sleep scientist setting up the sleep study equipment in the participant's home, for the participant to wear and sleep with overnight. The sleep study will measure: thoracic and abdominal respibands (respiratory effort); oxygen saturation measured continuously with the use of a pulse oximeter and a finger probe; transcutaneous carbon dioxide (PtcCO2) and ventilator data incorporated into the recording including mask pressure, total flow, tidal volume and leak. The equipment will then be collected by a physiotherapist or sleep scientist the following day. The study will be reviewed by unblinded clinicians to determine optimal NIV settings based on breath by breath analysis, within 72 hours of the monitoring. Experimental 2: Intervention In the ‘Experimental 2’ arm participants will receive adjustments to NIV settings based off 'Summarised' analysis of a polygraphy conducted at home. The participant will be guided to apply the oximeter probe via telehealth. There are no other differences in input for participants. This arm involves a physiotherapist or sleep scientist accessing a single-night's ventilator data remotely from a participants NIV device. This data will include mask pressure, total flow, tidal volume and leak with oxygen saturation measured continuously with the use of a pulse oximeter and a finger probe The study will be reviewed by unblinded clinicians to determine optimal NIV settings based on viewing summarised whole of night data, within 72 hours of the monitoring.
Sponsors
Institute for Breathing and Sleep, Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed