Title: Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to assess the effect on Health and Wellbeing in Older and Younger People.
Funder: Department of Health and Social Care

Abstract: Background: Obstructive sleep apnoea (OSA) affects up to 10% of the population, increasing to a third in older people and leading to cardiovascular, and neurocognitive consequences. Continuous positive airway pressure (CPAP) is the most effective treatment for OSA, however it is cumbersome and adherence is low. The newly developed vibro-tactile feedback may be beneficial for some patients, who have positional OSA. Aim: To determine whether Positional Therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional OSA, in reducing the disease severity and associated symptoms, compared to Sham-Positional Therapy. The interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age. Hypothesis: Positional Therapy reduces the severity of OSA, compared to Sham-Positional Therapy in patients with positional OSA. Additionally, efficacy is influenced by age. Methods: A prospective randomised, parallel, double-blinded trial comparing Positional Therapy (Night Shift&trade;; Advanced Brain Monitoring, USA) with Sham-Positional Therapy, performed in older (>65 years) and younger patients. Adult patients with positional OSA (apnoea/hypopnea index (AHI)>5 events/hour, 2:1 when supine) will be recruited from centres in the UK Respiratory Sleep Research Network and randomised, minimising for age group, BMI, gender, and OSA severity. OSA will be measured by a home study (Apnealink Air; ResMed, Australia). Patients subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. Partners or carers perspective will also be captured. Adherence to therapy will be measured. The primary endpoint, AHI at 3 months, will be measured by a repeat study with the device in situ, and compared between Positional Therapy and Sham-Positional Therapy. Analysis will be by regression of the final AHI with respect to treatment, adjusting for baseline AHI and age group. Secondary analysis will be the interaction between the treatment effect and age. Basic health economic data and cost-consequences of Positional Therapy will also be presented. A sample size of 138 is required to detect a treatment difference (AHI of 5 events/hour at 3 months). We will recruit 155 patients, powered to detect superiority of Positional Therapy compared to Sham at 90% power and 5% significance level, assuming within-group standard deviation of 9.05 events/hour, accounting for a 10% drop-out rate. Timelines for delivery: Recruitment at 6 patients/month, across 4-6 centres equals 25 months. Our timeline and delivery is informed by expertise from our previous trials and established infrastructure, enabling reduced set-up and costs. Adding analysis, write-up and dissemination, equals a total of 31 months. Anticipated impact and dissemination: Our patients have told us that Positional Therapy is an appealing option that is potentially less burdensome than CPAP. Our results will afford OSA patients a choice of treatments, especially for older patients. Results will be immediately disseminated, particularly through our partnership with patient charities. The vibro-tactile device is CE marked and available to use. We will also draw from our experience with successful UK trials to produce an information package for OSA patients that will empower them in their decisions about different treatments.

Lay abstract: Background: Obstructive Sleep Apnoea effects one in ten adults in the UK. It is caused by the muscles at the back of the throat relaxing during sleep. This results in the airway blocking and breathing stopping for several seconds every minute. The breathing restarts when the person wakes up, but waking-up a lot makes people sleepy. It can also cause long-term heart problems, and in older people increase the risk of having a stroke. The best treatment for obstructive sleep apnoea is Continuous Positive Airway Pressure (CPAP); it blows air into the lung and stops the airway closing, which in turn improves sleep. However, CPAP can be uncomfortable and difficult to use, especially for older people. Many patients only manage 2-3 hours CPAP usage a night, which is not enough to feel rested. Sleeping on the back makes the breathing worse for some patients with obstructive sleep apnoea. New developments in technology have resulted in companies making devices that use gentle vibrational feedback from position sensors to prevent people from sleeping on their back. Some of our patients have tried them and said they are comfortable, so we think they could be a useful treatment. Aims: To find out whether Positional Therapy, using a small vibrating device fitted to the neck, can help to stop people from sleeping on their backs and whether this helps to reduce the severity of their sleep apnoea. We also want to know whether patients feel better and specifically how easy the treatment is to use. We also want to know if the effect is different in older compared to younger people. Design and methods: The new Positional Therapy device will be compared to Sham-Positional Therapy. This is the best way of assessing a new treatment because the sham treatment is a placebo, where the patient thinks they are getting the treatment, but they are not. We will measure breathing at night to find out if the response to treatment changes and if this is different in older people. We will ask questions before and after 3 months of treatment to see if patients feel less sleepy and generally better. Patient and public involvement/Dissemination: Our patients often ask for alternative treatments to CPAP. The NHS is also looking for cheaper treatments that are easy to provide to patients. Our patient charity partner has told us that Positional Therapy devices look easy to use and recommend testing of the device. If vibration positional therapy is found to be helpful it could be recommended immediately, and patients made aware in different ways. To help inform patients, we will make an information package about treatment options. The trial results will also be available for inclusion in guidelines.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY