Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in Apnea Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
详细描述
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.
Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AHI score of ≥ 5
- •Body mass index (BMI) between 30 to 49.9 kg/m2
排除标准
- •Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event
- •Currently or planning to become pregnant during the next 9 months
- •Not weight stable (-4.6 kg) for 3 mos. prior to intake
- •Report current participation in a weight reduction program involving diet or PA
- •Unwilling to be randomized to 1 of 3 study groups
- •Report symptomology of an eating disorder as determined by the Eating Attitudes Test
- •Unable to participate in moderate intensity physical activity
研究组 & 干预措施
Low Calorie Diet
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
干预措施: Low Calorie Diet (Other)
Very Low Calorie Diet
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
干预措施: Very Low Calorie Diet (Other)
Standard Care
Participants will receive normal care.
干预措施: Standard Care (Other)
结局指标
主要结局
Change in Apnea Hypopnea Index (AHI)
时间窗: Change from Baseline to Month 3
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
次要结局
- Change in Daytime Sleepiness(Change from Baseline to Month 3 and Month 9)
- Change in Quality of Life(Change from Baseline to Month 3 and Month 9)
- Change in metabolic syndrome (MetS) risk factors(Change from Baseline to Month 3 and Month 9)
- Change in Apnea Hypopnea Index (AHI)(Change from Baseline to Month 9)