Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
2018年4月3日 更新者：University of Kansas Medical Center
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
37
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- AHI score of ≥ 5
- Body mass index (BMI) between 30 to 49.9 kg/m2
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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Weight management program designed around a low calorie diet.
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实验性的：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.
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Weight management program designed around a very low calorie diet.
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有源比较器：Standard Care
Participants will receive normal care.
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Care provided that would normally be given to people meeting eligibility criteria for this study.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Apnea Hypopnea Index (AHI)
大体时间：Change from Baseline to Month 3
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The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
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Change from Baseline to Month 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Apnea Hypopnea Index (AHI)
大体时间：Change from Baseline to Month 9
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The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
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Change from Baseline to Month 9
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Change in metabolic syndrome (MetS) risk factors
大体时间：Change from Baseline to Month 3 and Month 9
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Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
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Change from Baseline to Month 3 and Month 9
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Change in Quality of Life
大体时间：Change from Baseline to Month 3 and Month 9
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Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.
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Change from Baseline to Month 3 and Month 9
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Change in Daytime Sleepiness
大体时间：Change from Baseline to Month 3 and Month 9
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Researchers will administer Epworth Sleepiness Scale.
Results will be used to calculate daytime sleepiness changes for each participant.
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Change from Baseline to Month 3 and Month 9
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jeannine Goetz, PhD、University of Kansas Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2014年9月25日
首先提交符合 QC 标准的
2014年9月25日
首次发布 (估计)
2014年9月29日
研究记录更新
最后更新发布 (实际的)
2018年4月5日
上次提交的符合 QC 标准的更新
2018年4月3日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Low Calorie Diet的临床试验
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中