None listed
Conditions
Brief summary
Respiratory failure is the major cause of mortality and morbidity in patients with MND. Non-invasive ventilation provides respiratory support via a mask and machine and has become part of standard care for MND patients who develop sleep symptoms or respiratory failure. The current recommendations for NIV are mainly based on one study which reported that NIV prolonged survival and increased quality of life in a sub-group of patients with MND. However this study had only 22 patients in the NIV treatment group and NIV settings were changed based on patient tolerance and daytime blood gas changes, rather than in response to the type of abnormal breathing. In clinical practice, NIV is initially delivered during sleep, but is sometimes extended to the daytime as the disease progresses. The usual mode of NIV requires that the patient generates sufficient inspiratory effort to trigger pressure delivery by the machine. Inspiratory (and expiratory) pressure levels are usually chosen empirically without a sleep study. In a recent preliminary study including more systematic sleep studies, we found that NIV as currently provided to MND patients is suboptimal and in some instances may be dangerous. MND patients showed a variety of breathing abnormalities including obstructive apnea (a clinically silent variant not associated with snoring), central sleep apnea and varying levels of hypoventilation. Consequently, the traditional “one size fits all” approach to NIV treatment using empirically determined pressure settings is clearly sub-optimal. This project aims, for the first time, to characterize the patterns of abnormal breathing in MND patients and to investigate changes in breathing abnormalities as the disease progresses. We will also test the usefulness of a new “smart” ventilator in MND patients. This will help clarify the nature of gradually progressive deteriorations in breathing and how best to tailor treatments to improve breathing, sleep, quality of life and survival in patients with MND.
Interventions
This is an prospective observational study with a phase II randomised controlled arm. We have previously demonstrated( retrospective observational study) that patients with motor neurone disease( MND) develop a spectrum of various types of sleep disordered breathing.
Aims:
1. A prospective study of 40 patients to delineate the nature and time course of sleep disordered breathing in MND patients referred to the Repatriation General Hospital MND clinic for assessment.
2. Detailed sleep studies of
This is an prospective observational study with a phase II randomised controlled arm. We have previously demonstrated( retrospective observational study) that patients with motor neurone disease( MND) develop a spectrum of various types of sleep disordered breathing. Aims: 1. A prospective study of 40 patients to delineate the nature and time course of sleep disordered breathing in MND patients referred to the Repatriation General Hospital MND clinic for assessment. 2. Detailed sleep studies of Auto BiPAP ( using BiPAP A 40 AVAPS AE mode AE mode with auto pressure support, auto EPAP and auto back-up rate) vs. currently recommended BiPAP-S/T using a cross-over randomized 2 overnight study design ( consecutive nights), to assess the acute effects of each treatment in patients with respiratory failure, followed by randomization to one of the two treatments and clinical follow-up for 6 months ( minimum). This part of the study will include all the patients who meet the criteria for NIV as per the current guidelines. There is no washout period between the two nights, for the cross-over trial.
Sponsors
Vinod Aiyappan
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Age 18 or older b) Patients diagnosed to have MND as per El Escorial criteria c) Ability to give informed consent
Exclusion criteria
a) Patients already on NIV b) Cognitive impairment limiting the ability to participate in the trial c) Decompensated heart failure as defined by sudden or gradual onset of symptoms or signs of heart failure requiring unplanned clinic visits, hospitalization of emergency department visits within past 3 months or Left ventricular ejection fraction less than 40% d) Recent stroke (within 6 months)
Outcome results
None listed