Obstructive sleep apnoea (OSA) is a common chronic condition in the adult population that is characterized by repetitive episodes of upper airway collapse during sleep. Patients with OSA have feelings of tiredness and of needing to sleep during the day, called residual excessive daytime sleepiness (rEDS), which has a negative impact on their quality of life. This is a study of adults with OSA who are treated with a device they wear on their mouth and which helps them breath during sleep, called continuous positive airway pressure (CPAP). This population will be divided into those who have got or have not got rEDS. The frequency of rEDS will be estimated, and the two groups will be described and compared in several ways based on the existing electronic records: 1) geographic region, demographics, smoking status, the score from a questionnaire about sleepiness, concurrent disease and treatments, 2) health care resource use (HCRU) in primary and secondary care, including attendances at sleep services. The study will also investigate whether patients who wait longer from the time they are diagnosed to the time they start their treatment with CPAP, or to be seen in sleep services in hospital, have either a higher use of sleep services after starting using CPAP or, are more likely to have rEDS. The rational for the study is that it will provide knowledge that could be used to improve patient care and better manage the care pathway of these patients within the National Health Service.
Obstructive sleep apnoea (OSA) is a common chronic condition characterized by repetitive episodes of upper airway collapse during sleep, affecting patients’ quality of sleep. The standard treatment is with continuous positive airway pressure (CPAP), although some patients experience residual excessive daytime sleepiness (rEDS) on treatment. The aim of the study is to provide better understanding of OSA treated with CPAP, and of patients with and without rEDS.
The annual incidence and proportion of patients with any record of rEDS will be estimated in a study population of adults with CPAP-treated OSA identified from the Clinical Practice Research Datalink AURUM (CPRD). Subsets of the study population with and without rEDS after treatment will be described and compared for of the following: 1) characteristics including geographic region, baseline demographics, smoking status, Epworth Sleepiness Score (ESS) at baseline and follow-up, prior comorbidities and concurrent treatments (all from CPRD), 2) health care resource use (HCRU) in primary care (from CPRD) and secondary care (from Hospital Episode Statistics, [HES]), including sleep services (from HES and CPRD) post CPAP initiation.
Summary statistics will report frequencies and percentages for categorical variables and means, standard deviations, medians, interquartile ranges, and range for continuous variables. HCRU will be described as number of visits or inpatient spells per patient per year. Comparison between groups will use Chi-square tests for categorical variables, Student’s t-tests for normally distributed continuous variables or Wilcoxon rank sum tests for non-normal distribution. If numbers allow, the study will test for an association between time from diagnosis to (i) sleep services and (ii) start of CPAP treatment with regard to the following outcomes: (iii) the risk of rEDS during follow-up (using Cox regression modelling, adjusting for patient characteristics); (iv) the frequency of sleep clinic attendances post-CPAP initiation (using an adjusted generalized linear regression model).
rEDS; age, sex, geographic region ; smoking status; comorbidities (cardiovascular, psychiatric, gastrointestinal, obesity, sleeping disorders); comedications (antihypertensive, acid related gastric, non-steroidal anti-inflammatory, corticosteroids, psychiatric, central nervous system); ESS; and HCRU (primary care, secondary care inpatient, outpatient and accident and emergency, including sleep clinic attendances, sleep studies and road traffic accidents and full blood counts and thyroid function tests).
- Chief Investigator -
Ellen Hubbuck - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Laura Tolan - Collaborator - OPEN Health Group
Mark Evans - Collaborator - OPEN Health Group
Mark McCormack - Collaborator - Harvey Walsh Ltd
Peadar O'Donohoe - Collaborator - Jazz Pharmaceuticals (UK)
Myriam Alexander - Collaborator - Harvey Walsh Ltd
Myriam Alexander - Collaborator - OPEN VIE
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient