None listed
Conditions
Brief summary
Obstructive sleep apnoea (OSA) is a surprisingly common disorder and occurs due to upper airway obstruction. OSA is characterised by repetitive periods of obstructed breathing during sleep and is an independent risk factor for coronary artery disease, affecting 40%-60% of cardiac patients. Furthermore, untreated moderate to severe obstructive sleep apnoea (OSA) in patients with established coronary disease is associated with increased cardiovascular morbidity and mortality. Therefore, treating OSA in isolation is key for cardiovascular risk reduction. The purpose of this trial is to determine whether optimized OSA therapy can be achieved in a cardiovascular population using best-practice compliance enhancement strategies including digital patient engagement tools. Furthermore, we will assess the impact of optimized OSA therapy on surrogate markers of cardiovascular health. Collectively, we hypothesise, that optimised OSA therapy will be accepted and treatment adherence can be optimised in patients with coronary artery disease and that treatment will improve surrogate markers of cardiovascular health.
Interventions
Enrolled patients will be randomised into either the personalised obstructive sleep apnea (OSA) treatment group or usual medical care. The patients randomised into the personalised OSA treatment group will select either continuous positive airway pressure (CPAP) therapy or oral appliance therapy (OAT) based on physician recommendations and personal preference.
ARM 1: Personalised OSA treatment group, (CPAP or OAT)
CPAP therapy:
CPAP therapy will be overseen by an experienced sleep therapist o
Enrolled patients will be randomised into either the personalised obstructive sleep apnea (OSA) treatment group or usual medical care. The patients randomised into the personalised OSA treatment group will select either continuous positive airway pressure (CPAP) therapy or oral appliance therapy (OAT) based on physician recommendations and personal preference. ARM 1: Personalised OSA treatment group, (CPAP or OAT) CPAP therapy: CPAP therapy will be overseen by an experienced sleep therapist over the intervention period of six-months. The sleep therapist will provide detailed CPAP therapy education to the patient during the first CPAP initiation visit (face to face). Patients are allowed to acclimatise to CPAP therapy over a period of approximately 8 weeks. This may include monthly phone calls and face to face visits as required. CPAP device settings may be adjusted in accordance with the patient’s feedback to optimize CPAP compliance and use. The intervention period begins when the patient is determined to be acclimatised to CPAP therapy (apnoea-hypopnea index <15 events/h and usage >5 hours per night). Patients who fail to meet this criterion will be offered oral appliance therapy or combination therapy. Ongoing remote support will be maintained during the six-month intervention period. Remote monitoring of CPAP therapy usage will be conducted on a cloud-based patient management system. Patient engagement tools (ie. cloud-based mobile application) will be used to allow patients to receive feedback on their CPAP use during the intervention period. Oral appliance therapy: A custom-made oral appliance will be delivered by an experience dentist. Patients will undergo an oral health assessment with the dentist to determine suitability for oral appliance therapy. Patients not eligible for an oral appliance will be offered CPAP therapy. Patients are allowed to acclimatise to oral appliance therapy for approximately eight weeks. This involves establishing the optimum jaw position for comfort and resolution of OSA symptoms as assessed by the study dentist. The intervention period begins when the patient is determined to be acclimatised to oral appliance therapy (apnoea-hypopnea index <15 events/h and usage >5 hours per night). Patients who fail to meet this criterion will be offered CPAP therapy or combination therapy. Patients on oral appliance therapy will be asked to complete an online sleep diary daily for remote monitoring of therapy. Ongoing remote support will be maintained during the six-month intervention period. ARM 2: Usual care This will represent a control group receiving conventional medical care by their cardiologist and primary care physician.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a recent (within 12 months of diagnosis) presentation of acute coronary syndrome (unstable angina, ST elevated myocardial infarction (EMI), non-STEMI). 2. Patients diagnosed with moderate to severe obstructive sleep apnoea with significant hypoxia defined as an Oxygen Saturation Index 3% (ODI 3%) > 10 events/hour on polysomnogram. 3. Clinically suitable for PAP and/or OAT treatment. 4. Willingness to undergo either PAP, OAT or usual care for 6 months.
Exclusion criteria
1. Previous treatment for obstructive sleep apnea. 2. Contraindications to CPAP (severe nasal obstruction) or oral appliance therapy (insufficient teeth or dental health issues). 3. Women who are lactating or pregnant 4. Driving risk, report an accident (or near miss accident) because of sleepiness in the last 6 months 5. Need for immediate therapy as assessed by treating sleep physician. 6. Patients with a history of psychological illness or conditions such as to interfere with the patients ability to understand the requirements of the study 7. Coexisting sleep disorder, shift work, regular use of sedatives or narcotics, pre-existing lung disease (moderate to severe chronic obstructive pulmonary disease) or psychiatric disease; chronic kidney disease (eGFR<60). 8. Central sleep apnea (defined as >20% of respiratory events being central events, rather than obstructive events)
Outcome results
None listed