The clinical effectiveness of a simple new treatment for supine-dependent obstructive sleep apnoea

None listed

Brief summary: Obstructive sleep apnoea (OSA) is the most common form of pathological breathing in sleep. It is characterised by frequent upper airway collapse, recurrent brief arousals that severely disrupt sleep, and marked repetitive oxidative and cardiovascular system stress. OSA has serious adverse health and quality of life consequences, including severe daytime sleepiness, cognitive impairment, a 2-fold increased risk of motor vehicle and other accidents, and hypertension. Of those patients diagnosed with OSA around 30% exhibit clinically significant symptoms only when supine. Although a number of supine avoidance therapies are available and generally effective (e.g. classic tennis ball devices designed to make supine sleep uncomfortable), all have problems that limit clinical utility. In a follow-up survey of patients established with a traditional tennis ball device, we found that over 90% of patients stopped using treatment within a median time of 1 month, primarily due to excessive discomfort. The acceptability of supine-avoidance therapy as a mainstream treatment for appropriately selected patients relies upon substantiating practical, acceptable and low cost methods to discourage supine sleep. The BuzzPOD (Gorman ProMed Pty. Ltd) is a position monitoring device, worn on the chest, employing a vibration function designed to discourage supine sleep whilst minimally disturbing the patient and bed partner. A previous small, randomised, controlled, cross-over pilot study of active versus inactive treatment (1 week of each with 1 week washout) in 14 patients confirmed that the device almost completely abolished the supine posture and usefully improved OSA severity. Adherence to treatment was high. Total use over the full 3 week trial was (mean+/-SD) 85%+/-23% of nights, 6.8+/-2.3 h per night including zero hours when not worn, and 8.0+/-1.2 h on nights when worn. These average nightly compliance values are around twice those typically reported for CPAP treatment in mild OSA (3.5+/-2.1 h/night). Compliance was maintained at that level for several months in several of the patients who agreed to a longer period of post-study surveillance. Thus, we believe there is now sufficient evidence to support a more rigorous longer-term trial of supine-avoidance therapy. The study intends to recruit 140 patients with supine-predominant obstructive sleep apnoea. Patients will receive both treatments in a randomly allocated order; the control arm will be standard, clinical, best-practice CPAP treatment, the experimental arm will be receive BuzzPOD supine-avoidance therapy. Patients will receive each treatment for 8 weeks, and will attend follow-up assessments just prior to concluding each treatment. It is expected that supine avoidance therapy in patients with positional OSA will achieve improvements in daytime sleepiness and quality of life that are not inferior to those following CPAP, and be better tolerated than conventional CPAP treatment.