When used, continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnea (OSA), a condition that is mainly caused by overweight and obesity. However, CPAP is plagued by poor adherence and high rates of discontinued use leaving most patients undertreated and at risk of serious health complications. This study aims to test whether new effective weight loss pharmacotherapy is superior to CPAP for alleviating OSA and improving health outcomes.
Females and Males aged ≥ 18 years at the time of signing informed consent
Moderate-severe OSA defined as an AHI ≥ 15/hr determined from a Type 1 or 2 sleep study conducted within the previous 12 months with a clinician recommendation for CPAP therapy.
Moderate overweight or obesity defined as BMI ≥ 27 kg/m2. (Adjusted to BMI ≥ 25 kg/m2 for Asian populations as per WHO guidelines (WHO Expert Consultation (2004))
No contraindication to tirzepatide use as per Australian Product Information
Respiratory failure including obesity hypoventilation syndrome (OHS) or daytime hypercapnia or moderate-severe chronic obstructive pulmonary disease (COPD) with FEV1/FVC ratio<0.7 and FEV1<80% predicted (GOLD criteria).
Driver occupation with excessive sleepiness (Epworth Sleepiness Scale >=16) or sleepiness-related motor vehicle accident or near accident within 12 months prior to enrolment
Current or prior (≤3 months) OSA treatment with mechanical therapy (CPAP, MAS, Positional)
>50% respiratory events with Cheyne-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)
Parallel
Continuous Positive Airway Pressure
DeviceParticipants allocated to CPAP will be managed by their caring sleep physician as per their normal practice. Participants may also be counselled on losing weight with diet and exercise as per usual practice.
Tirzepatide
DrugPatients allocated to weight loss with tirzepatide will be managed by the study dietitian. The tirzepatide formulation is administered subcutaneously once weekly using single-use injection pens. Participants will undergo a 20-week dose escalation phase followed by a dose maintenance phase for the remainder of the 12-month study period.
Breathing Disturbance Index (BDI)
BDI is the primary severity metric of OSA in the trial which is measured by the number of breathing disturbances per hour of sleep. This is measured using contactless mattress-based OSA monitors (SleepTracker-AI) that can automatically and reliably measure true OSA alleviation every night for the entire period of sleep.
Hypoxia - Oxygen Desaturation Index (ODI 3%)
ODI 3% is calculated as the number of oxygen desaturation events ≥3% per hour as a percentage of time in bed, estimated using at-home oximetry (RingConn Gen 2).
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a Score
The PROMIS Sleep-Related Impairment Short Form 8a Score is used to assess participant-reported levels of alertness, sleepiness, and tiredness and the functional impairments associated with sleep problems or reduced alertness over the past 7 days.
Epworth Sleepiness Scale (ESS)
Subjective sleepiness scored out of 24 measured using an 8-item questionnaire.
Ambulatory Blood Pressure - Sleep Systolic Blood Pressure (SBP)
Sleep SBP is measured hourly, using an ambulatory blood pressure monitor, for a self-reported sleep period.
Hypoxic Burden
This is an oximetry-derived measurement using established algorithms. Hypoxic burden measures are quantified from nightly at-home oximetry acquired using an oximeter device (RingConn Gen 2).
Short Form Functional Outcomes of Sleep Questionnaire (FOSQ-10)
The FOSQ-10 is used to assess the impact of sleep disorders/excessive sleepiness on daily functioning.
Cardiometabolic Fasted Blood Markers - Glucose
Glucose is measured from fasted venous blood.
Cardiometabolic Fasted Blood Markers - Triglycerides [TAG]
Triglycerides are measured from fasted venous blood.
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