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

INTERVENTION: 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: Inte CONDITION: Chronic hypercapnic respiratory failure;Neuromuscular disease;Chronic obstructive lung disease (COPD);Restrictive thoracic disease;Obesity hyperventilation syndrome; ; Chronic hypercapnic respiratory failure ; Neuromuscular disease ; Chronic obstructive lung disease (COPD) ; Restrictive thoracic disease ; Obesity hyperventilation syndrome Neurological ‐ Neurodegenerative diseases Public Health ‐ Health service research Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: NIV 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).] 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 SECONDARY OUTCOME: Composite outcome of Treatment failure.[Average NIV usage < 4 hours in previous 4 weeks Or PaCO2 > 50 mmHg Or Admission to hospital Or Death. NIV usage will be recorded by the NIV device, and averaged over four weeks. PaCO2 > 50 mmHg will be assessed by arterial blood gas. Admission to hospital will be assessed by medical records and patient self‐report. Death will be assessed by electronic medical records. Post NIV implementation at Week 4, Week 16.] Control of Respiratory Failure On Therapy.[Nocturnal SpO2. Oxygen saturation will be assessed continuously with the use of a pulse oximeter and a finger probe at night while on NIV. Post NIV implementation at Week 16.] Control of Respiratory Failure On Therapy[TcCO2, measured using transcutaneous capnography at night while on NIV. Post NIV implementation at Week 16.] Feasibility.[Number of face to face contacts with staff, determined from medical records and study records. Throughout trial period.] Feasibility.[Proportion of successful sleep studies from which recommendations are made, determined from medical records and study records. Throughout trial period.] Feasibility.[Time (days) from randomisation to analysis method and from analysis method to setting adjustments, determined from medical records and study records. Throughout trial period.] Feasibility[Staff travel time (hours), determined from medical records and travel diaries. Throughout trial period.] Healthcare utilisation.[Electronic medical records. Post NIV implementation at Week 4, Week 8, Week 12, Week 16.] Measures of C02 off ventilation.[Arterial Blood Gas (ABG) or CAPGas (capillary sampling) where an ABG is not obtainable. Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Patient reported outcome: Comfort on ventilator.[Measured on the S3 Questionnaire and Ventilation Questionnaire. Post NIV implementation at Week 4, Week 8, Week 12, Week 16.] Patient reported outcome: Daytime somnolence.[Measured on the Epworth Sleepiness Scale (ESS). Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Patient reported outcome: Daytime somnolence.[Measured on the Karolinska Sleepiness Scales (KSS). Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Patient reported outcome: Dyspnoea.[Measured on the Modified Borg Scale (MBDS). Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Patient reported outcome: Dyspnoea.[Measured on the Modified Medical Research Council Dyspnea Scale (mMRC). Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Patient reported outcome: Health‐related quality of life.[Measured on the Assessment of Quality of Life (AQoL). Prior to NIV implementation, and post NIV implementation at Week 16.] Patient reported outcome: Health‐related quality of life.[Measured on the Calgary Sleep Apnoea Quality of Life Inde X(SAQLI). Prior to NIV implementation, and post NIV implementation at Week 16.] Patient reported outcome: Health‐related quality of life.[Measured on the Severe Respiratory Insufficiency questionnaire (SRI). Prior to NIV implementation, and post NIV implementation at Week 16.] Patient reported outcome: Sleep quality.[Measured on the Pittsburgh Sleep Quality Inde X(PSQI). Prior to NIV implementation, and post NIV implementation at Week 4, Week 16.] Safety.[Number of adverse events defined according to existing health service clinical guidelines, determined from medical records and study records. Throughout trial period.]