A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Post treatment weight (kg)
研究概览
简要总结
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
详细描述
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Primary Objective
- To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care.
- To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI).
Secondary Objective
- To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life.
- To determine if metabolic parameters (e.g., lipids, glucose) improve.
- To determine if there is improvement in sleep structure and oxygenation during sleep.
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
- •Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea
- •Patients with an age over 18 years
- •Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA)
- •Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2
- •Patients who have an Epworth Sleepiness Scale score ≤11
排除标准
- •Patients will not be recruited:
- •if they are on weight loss medications
- •if they have seen a registered dietician in the preceding 6 months for dietary counseling
- •if they have attended a weight loss program in the last 6 months
- •if they have a history of a car accident related to sleepiness or report sleepiness when driving
- •if they work in a safety critical occupation and require treatment for work reasons
- •if they have serious or unstable cardiac co-morbidity
- •if they are unable or unwilling to provide informed consent
- •if they are pregnant
- •if they are unwilling to return for follow-up visits
结局指标
主要结局
Post treatment weight (kg)
时间窗: 6 months
次要结局
- Change in snoring (Visual analogue scale)(6 months)
- Quality of life (FOSQ)(6 months)
- Excessive daytime sleepiness (ESS)(6 months)
- Waist-hip ratio (WHR)(6 months)
- Blood pressure(6 months)
- Lipid and glucose levels(6 months)
- Sleep fragmentation(6 months)
- Oxygen saturation(6 months)
- Post treatment AHI(6 months)