A randomised controlled trial of continuous positive airway pressure treatment in older people with obstructive sleep apnoea hypopnoea syndrome (PREDICT)
A CPAP mask could become a standard treatment for people over 65 who stop breathing during sleep, but only if a new trial proves it works and is worth the cost in this age group. Obstructive sleep apnoea hypopnoea syndrome (OSAHS) causes the throat to block during sleep, repeatedly stopping breathing and leaving patients exhausted during the day. CPAP—a mask that delivers pressurised air—is already a proven, cost-effective treatment for middle-aged people. But almost no evidence exists for patients over 65, who may respond differently or have other health issues that complicate treatment. The PREDICT trial will randomly assign 278 patients aged 65 and older to receive either CPAP plus best supportive care, or best supportive care alone, then monitor them for 12 months. If CPAP reduces daytime sleepiness and proves cost-effective in older people, the NHS could routinely offer it to this age group. That would improve quality of life for thousands of older adults and potentially reduce healthcare costs linked to untreated sleep apnoea, such as falls, cognitive decline, and cardiovascular strain. The trial will also produce the first detailed health-economic data on CPAP in any older population, helping NICE decide whether to fund it.
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Obstructive sleep apnoea hypopnoea syndrome (OSAHS) is the name given to difficulty in breathing during sleep due to blockage of the throat. It causes patients to stop breathing, which leads to disturbed sleep and excessive daytime sleepiness. OSAHS can be treated with continuous positive airway pressure (CPAP), which works by the patient breathing pressurised air through a mask (like an oxygen mask). A recent NICE review concluded that CPAP is a cost effective treatment for OSAHS in middle aged people. Unfortunately very little information is available regarding the best way to treat OSAHS in older people. We think that treating OSAHS may provide a cost effective way of improving health and optimising quality of life in older people. This study will measure the effect of treating OSAHS on daytime sleepiness in patients over 65 years. It will also tell us whether CPAP is cost effective in this age group. 278 patients will be studied. Half will receive both CPAP and a package of care called 'Best Supportive Care', and half will receive 'Best Supportive Care' alone. Best Supportive Care consists of guidance on sleep habits, weight loss and a review of all health-related issues. Before patients agree to take part in the study it will be explained that they may be allocated to either of these two treatment approaches. This 'randomisation' is the best way to test the effectiveness of a treatment. Each group will be monitored for 12 months. The information collected will be analysed using the standard methods of NICE. The results from this trial will establish whether or not older people with OSAHS should be offered CPAP treatment, and whether it is good value for money in older people. The trial will generate the first substantial and detailed randomised data set (in any population) directly describing the health economic consequences of CPAP therapy in OSAHS.
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