Cardio-metabolic health effects of CPAP treatment for sleep apnoea during weight loss: A Randomised Controlled Pilot Trial

Woolcock Institute of Medical Research, University of Sydney0 个研究点目标入组 17 人开始时间: 2017年6月6日最近更新: 2021年3月22日

适应症

试验速览

暂无简介。

•1. Community dwelling adults aged 18-65 years
•2. Waist circumference: females >88cm, males >102cm
•non-European: famales >80cm, males >90cm
•and/or BMI >=27kg/m2
•3. Pre-diabetes defined per World Health Organisation as any of the following recent (<3 months) findings:
•a) impaired fasting glucose with BGL between 5.5 and 7.0 mmol/L;
•b) impaired glucose tolerance with BGL between 7.8 and 11.0 mmol/L after a formal 75g OGTT;
•c) HbA1C between 6 and 6.5%
•4. Moderate-severe hypoxaemic OSA with AHI>=20/hr and ODI>=10/hr prior to VLED induced weight loss, based on recent (<12 months) polysomography

•1. Any known contraindications to VLED or exercise
•2. Recent weight loss that in the opinion of the treating physician is clinically significant
•3. Current or recent (<3months) treatment of OSA
•4. Professional drivers who are sleepy
•5. Recent (<6 month) history of fall-asleep car crashes or near miss accidents
•6. Excessive sleepiness that in the opinion of the treating physician requires immediate CPAP treatment
•7. Severe medical (including renal failure) or psychiatric co-morbidity
•8. Unstable medical conditions (hypertension, cardiac)
•9. Recent use of illicit drugs or alcohol dependence
•10. Current (or recent <3 months) use of hypoglycaemic agents
•11. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
•12. Respiratory failure including obesity hypoventilation syndrome (OHS) (OHS as diagnosed by physician, based on standard criteria including: BMI >30kg/m2, arterial PaCO2 >45 and evidence of prolonged periods of hypoventilation and hypoxemia during sleep)

发起方

Woolcock Institute of Medical Research, University of Sydney