ACTRN12613000191796已完成未知
Weight loss lifestyle intervention for obese adults with sleep apnea to investigate the effect of treatment on sympathetic activity and cardio-metabolic outcomes.
The Woolcock Institute0 个研究点目标入组 42 人开始时间: 2013年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •The following inclusion criteria enable the volunteer to participate in the SLEEEP Study:
- •Males & Females aged 18-65 years.
- •General or central obesity: BMI: greater than or equal to 30kg/m2 (greater than or equal to 26kg/m2 amongst non-Europeans) or waist circumference greater than or equal to 88cm for women and greater than or equal to 102cm for men (greater than or equal to 90cm in men and greater than or equal to 80cm in women who are non-European).
- •Willing and medically able to participate in a supervised very low energy diet (Optifast) and the dietary and lifestyle modification groups for a 12 month period.
- •Mild-severe, symptomatic OSA (degree of symptoms at the treating physician’s discretion based on overnight sleep study report)
- •No history of or current presence of eating disorders , significant/extensive food allergies or significant food intolerances (e.g. coeliac disease)
- •Willing and able to complete all assessments outlined in participant information sheet
- •Hold a current driver’s license or have access to transport.
排除标准
- •Unstable aortic aneurysm
- •Rapidly progressive or terminal illness
- •Severe left ventricular dysfunction/end stage congestive heart failure
- •Severe aortic stenosis
- •Severe psychosis or behavioural disturbance or cognitive impairment
- •Patients known to be involved in illegal activity
研究者
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