None listed
Conditions
Brief summary
Not being able to breath enough overnight is a major problem for an increasing number of Australians with obesity. Obesity hypoventilation syndrome, as this problem is known, is now the major reason for complex, overnight breathing support in Australia. This potentially fatal disease can be managed using two different strategies; a cheaper, simpler option available to more people or a more expensive approach that requires specialised services. The more complex approach may not be better if fewer people are able to take advantage of it. In this twelve month study, people with obesity hypoventilation syndrome will be randomised (like flipping a coin) to receive either the simple or the complex way of managing the disease. The primary question we are looking to answer is whether the more complex approach is really better than the simpler one. Specifically, the study will determine which treatment is better for patients in terms of quality of life, blood test results and and how easily they can get out and about. The study will also help establish which of these approaches is more cost-effective for the community.
Interventions
Two commonly used non-invasive ventilation strategies in the respiratory management of patients with stable Obesity Hypoventilation Syndrome will be compared.
i) Bilevel PAP (positive airway pressure): use of bilevel ventilation set in a spontaneous-timed mode versus
ii) CPAPplus: Initial treatment with continuous positive airway pressure (CPAP), with progressive escalation of ventilatory support in case of treatment failure to spontaneous bilevel PAP and then bilevel in the spontaneous-timed m
Two commonly used non-invasive ventilation strategies in the respiratory management of patients with stable Obesity Hypoventilation Syndrome will be compared. i) Bilevel PAP (positive airway pressure): use of bilevel ventilation set in a spontaneous-timed mode versus ii) CPAPplus: Initial treatment with continuous positive airway pressure (CPAP), with progressive escalation of ventilatory support in case of treatment failure to spontaneous bilevel PAP and then bilevel in the spontaneous-timed mode if needed. Note i) Bilevel PAP involves the delivery of positive pressure through a nasal mask. The pressure delivered during inspiration is higher than that during expiration. These pressures act to "splint" the upper airway open and to increase the size of each assisted breath. The pressures used are estimated during a daytime familiarisation trial and confirmed during an overnight sleep study. The mask and device are to be used every night during sleep throughout the study period, ie 12 months. The delivered pressures will be in the range of 4-30cm H2O as observed in usual clinical practice. ii) CPAP involves the delivery of a constant positive pressure through a nasal mask. The pressure delivered is constant across both inspiration and expiration. This pressure act to "splint" the upper airway open during sleep. The pressures used are estimated during a daytime familiarisation trial and confirmed during an overnight sleep study. The mask and device are to be used every night throughout the study period, ie 12 months. The delivered pressures will be in the range of 4-30cm H2O as observed in usual clinical practice. Primary endpoint will be made at 3 months, with secondary endpoint at 12 months
Sponsors
Institute for Breathing and Sleep
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary diagnosis of Obesity Hypoventilation Syndrome Body mass index >30kg.m-2 Daytime respiratory failure with a PaCO2>45mmHg At randomization, pH is in the normal range for chronic hypercapnia FEV1/FVC ratio >70%
Exclusion criteria
Hypoventilation attributable to other causes eg neuromuscular disease, chest wall abnormalities, multiple medications with sedative/respiratory depressant side-effects Physician diagnosed chronic obstructive pulmonary disease Has used non-invasive ventilation (Bilevel PAP or CPAP) for more than one month in the previous 3 months. Not proficient in English Inability to provide informed consent
Outcome results
None listed