Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea: A Randomised Comparative Effectiveness Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Breathing Disturbance Index (BDI)
研究概览
简要总结
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.
详细描述
The TIRZE-PAP study is a parallel randomised superiority trial comparing weight loss with weekly tirzepatide (15mg or the maximum tolerated dose) versus CPAP, in 256 people with moderate-severe OSA (AHI≥15/hr) and overweight or obesity (BMI: ≥27kg/m2). Participants allocated to CPAP will receive therapy as per usual care by their treating physician. Participants allocated to tirzepatide will undergo a 20-week stepped titration with a monthly increase of dose to a maximum 15mg (or maximum tolerated) by week 20. Outcomes will be collected over two 28-day periods commencing at baseline (pre-intervention weeks -4 to 0) and at follow-up (post-intervention weeks 48 to 52).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •(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
- •Home internet access to enable cloud storage of SleepTracker-AI in-home BDI.
- •Fluent English literacy and able to provide informed consent.
排除标准
- •OSA or other respiratory related criteria:
- •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)
- •Relative or absolute contraindication to CPAP including chronic cranial injury; recurrent pneumothorax; indication for oral-pharyngeal surgery, significant craniofacial abnormalities that may affect breathing, or are unwilling to use CPAP
- •Any previous or planned surgery for OSA or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing (NB: Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion)
- •Glycaemia related criteria:
- •HbA1c ≥ 48 mmol/mol (6.5%) at screening
- •Type 1 or type 2 diabetes mellitus
- •Treatment with glucose-lowering agent(s) within 90 days before screening
- •Treatment with a GLP-1 receptor agonist within 90 days before screening
- •Obesity related criteria:
- •A self-reported change in body weight >5 kg or >5% within 90 days before baseline
- •Treatment with medication for the indication of obesity within 90 days before baseline and/or currently enrolled in a weight loss program
- •Other criteria:
- •Pregnancy/breast feeding or planning a pregnancy during the trial period
- •Relative or absolute contraindication to tirzepatide including needle phobia
研究组 & 干预措施
Continuous Positive Airway Pressure (CPAP)
干预措施: Continuous Positive Airway Pressure (Device)
Tirzepatide
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Breathing Disturbance Index (BDI)
时间窗: The mean BDI measured over 28 nights of monitoring is calculated for baseline (Weeks -4 to 0) and follow-up (Weeks 48 to 52)
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.
次要结局
- Hypoxia - Oxygen Desaturation Index (ODI 3%)(ODI 3% will be determined as a mean of 7-10 nights of data acquired at baseline and a mean of 7-10 nights of data acquired at 12month follow-up.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a Score(Collected at Baseline and 3,6,9 and 12 months.)
- Epworth Sleepiness Scale (ESS)(Collected at Baseline and 3,6,9 and 12 months.)
- Ambulatory Blood Pressure - Sleep Systolic Blood Pressure (SBP)(Baseline and Week 52)
- Cardiometabolic Fasted Blood Markers - Low-Density Lipoproteins (LDL)(Screening and Week 52)
- Cardiometabolic Fasted Blood Markers - HbA1c(Screening and Week 52)
研究者
Craig Phillips
Associate Professor
Woolcock Institute of Medical Research