Exacerbation prevention in chronic obstructive pulmonary disease (COPD) – obstructive sleep apnoea (OSA) overlap syndrome: The clinical and health economic impact of treating patients with COPD-OSA overlap syndrome and a high risk of future exacerbations with positive airway pressure therapy (PAP) a multicentre randomised controlled trial
Respiratory
This is a multi-centre randomised controlled trial in patients with COPD-OSA overlap and a high risk of exacerbations. Participants will be randomised via a web-based, pre-programmed randomisation system with minimisation for Epworth sleepiness score (<11 or ≥11), current long-term oxygen therapy use (Y/N) and study site, to receive home PAP and usual COPD care or usual COPD care alone with a 12-month follow-up period. Several methods will be used to identify patients. Patients will be identified by clinical teams when attending clinical review in COPD clinics, rehabilitation services or sleep clinics. Where appropriate, patients who have attended community diagnostic centres for spirometry and have results consistent with COPD will be screened. Lastly, where possible local screening databases will be used to identify additional patients with COPD. Where possible clinical teams will be asked to record STOP-BANG and Epworth Sleepiness Score (ESS), if this is not feasible at the clinical visit, this will be done at screening. If patients meet the inclusion requirement they will be asked to consent to the study and undergo a sleep study. Following the sleep study patients with moderate to severe OSA will be randomised to PAP therapy or usual care. At baseline assessment (visit 1) medical history, drug history and COPD clinical history will be recorded. Participants will also be asked to complete questionnaires including CAT, EQ-5D-5L, eMRCD score, Pittsburgh sleep quality index and Epworth Sleepiness Score. Spirometry (lung function testing will also be undertaken. Participants will then be reviewed at 3 and 12 months and all of the assessments in the baseline visit are repeated. In addition, PAP usage data will be recorded as well and any support for PAP therapy will be given. Participants will also be contacted every month to: 1. Record health care utilisation 2. Exacerbations (number and treatment given) 3. Medication changes 4. Use of PAP therapy and if any
1. Moderate-severe COPD (GOLD grade 2-4) 2. High risk of future exacerbations: 1 severe (hospital assessed) exacerbation or 2 moderate (community clinician assessed) in the last 12 months 3. Moderate-severe OSA (AHI ≥ = 15/h)
1. Clinically significant or severe daytime sleepiness: Epworth Sleepiness score > 15 or excessive sleepiness likely to impair safe driving in current drivers (as evidence has already established that such patients should be treated with PAP therapy) 2. Significant hypercapnic respiratory failure at baseline assessment (PaCO2 > 6kPa, with evidence already indicating these patients should be treated with NIV) 3. PAP therapy mandated by the treating clinician due to the severity of the sleep symptom burden 4. Professional driver or other vigilance essential role with significant daytime sleepiness 5. Currently enrolled in an interventional clinical trial