NCT05335083尚未招募不适用
The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - an Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Mean 24 hour glucose difference between the CPAP on and CPAP off conditions
研究概览
简要总结
The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
详细描述
Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community dwelling adult males and females aged 18-65 years
- •Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15/hr within the past 60 months
- •Able to give written informed consent
- •Proficient in English
- •Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (<3 months) findings:
- •Fasting glucose with a BGL <7.0 mmol/L
- •Glucose tolerance with a 2-hour BGL of < 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)
- •HbA1C of ≤ 6.5%
- •Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.
排除标准
- •Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)
- •Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study.
- •Regular (>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)
- •Regular night shift work or travel overseas within the last 2 weeks
- •Sleep physician has advised against CPAP withdrawal
- •Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (>300 mg a day) or recent (in the past month) use of illicit drugs
- •Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
- •Current or recent (<3 months) use of hypoglycaemic agents
- •Undergoing a weight loss programme
- •Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.
结局指标
主要结局
Mean 24 hour glucose difference between the CPAP on and CPAP off conditions
时间窗: 2 weeks
Average 24 hour glucose difference between CPAP on and CPAP off conditions
次要结局
- Mean daytime glucose difference between the CPAP on and CPAP off conditions(2 weeks)
- Change in Glucose Management Indicator(2 Weeks)
- Mean night time glucose(2 weeks)
- Coefficient of Variation(2 Weeks)
- SD of Mean Glucose(2 Weeks)
- Time in Tight Range (TITR)(2 Weeks)
- Glucose tolerance(2 weeks)
- Time in Range (TIR)(2 Weeks)
- Time Below Range (TBR)(2 Weeks)
- Time below Range <3.0 mmol/L(2 Weeks)
- Time Above Range (TAR)(2 Weeks)
- Time Above Range >13.9 mmol/L(2 Weeks)
- Extended hypoglycaemic event rate(2 Weeks)
- Extended hyperglycaemic event(2 Weeks)
- TIR >70%(2 Weeks)
- TIR improvement at least 5%(2 Weeks)
- TIR improvement at least 10%(2 Weeks)
- TBR <3.9 mmol/L <4%(2 Weeks)
- TBR <3.0 mmol/L <1%(2 Weeks)
- TAR >10.0 mmol/L >25%(2 Weeks)
- TAR >13.9 mmol/L <5%(2 Weeks)
- Hypoglycaemia(2 Weeks)
- Hypoglycaemia Alert Value (Level 1)(2 Weeks)
- Clinically Significant Hypoglycaemia (Level 2)(2 Weeks)
- Extended Hypoglycaemia(2 Weeks)
- High Glucose Level (Level 1)(2 Weeks)
- Very High Glucose (Level 2)(2 Weeks)
- Extended Hyperglycaemia(2 Weeks)
研究者
研究点 (4)
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