Effectiveness of Compression Stocking on Overnight Fluid Shift in Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Compression stocking improves ODI of OSA patients
研究概览
简要总结
Overnight rostral fluid shift is one of the contributing factors for worsening obstructive sleep apnoea (OSA). Fluid shift has been recognized to play a role in the pathophysiology of sleep apnoea. Previous studies shown that fluid from the leg redistributes to the neck at night increases the neck circumference, hence indicating fluid accumulation in the neck. OSA patients are more susceptible to developing upper airway narrowing in response to fluid shift from the leg to the head and neck region.
Previous studies were mainly done on Caucasian patients. The pathophysiology of OSA in Caucasian patients and Asian patients are different but both suffer a similar degree of OSA. The investigators would like to investigate if reducing leg swelling by a simple non-invasive intervention of wearing compression stocking during the day can attenuate sleep apnoea, and whether compression stocking is generally acceptable and well-tolerated among the general OSA population in Asia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30 years old to 65 years old.
- •Either STOP-Bang score of ≥3 or Epworth sleepiness scale indicating mild excessive daytime sleepiness to severe excessive daytime sleepiness (11-24 points).
- •Has pre-existing diabetes mellitus and/or hypertension and is on medication.
- •Ability to provide informed consent.
- •Not working night shift.
排除标准
- •Significant arterial disease due to the risk of limb ischaemia and necrosis.
- •Not pregnant and not planning to get pregnant before the end of the study.
- •History of psychiatric disease.
- •Patient who are on wheelchair.
- •Patient who has cardiac failure and or stroke.
- •Patient who has end-stage renal failure. Estimated glomerular filtration rate <15ml/min/1.73m2 or on renal replacement therapy i.e. dialysis or renal transplant.
- •Patient who has liver disease.
- •Patient who are on pacemaker, and metal implants.
- •Patient who are on CPAP treatment for OSA.
- •Patient who are illiterate.
- •Medications which affect fluid balance or level of consciousness (e.g. diuretics, non- steroidal anti-inflammatory drugs (NSAIDS), corticosteroids, sedatives, opiates) at any time during the study.
研究组 & 干预措施
Below the knee compression stocking
干预措施: Compression stocking (Device)
结局指标
主要结局
Compression stocking improves ODI of OSA patients
时间窗: 2 weeks
Bioelectrical impedance analysis (BIA) readings performed before wearing the compression stocking and 2 weeks after wearing the compression stocking to assess the total body water, lower limb total water content (LLW), lower limbs extracellular water content (ecLLW), trunk total water content (TW), trunk extracellular water content (ecTW), neck fluid volume and leg fluid volume will be improved. Calf and neck circumference measurements before wearing the compression stocking and 2 weeks after wearing the compression stocking will be improved. Sleep test done to measure the Oxygen Desaturation Index (ODI) the night before wearing the compression stocking and 2 weeks before the final visit to the clinic will be improved.
次要结局
未报告次要终点