Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy (HYPNOS)
2021年5月3日 更新者：Johns Hopkins University
This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.
研究概览
详细说明
Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes.
Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control.
However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined.
Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction.
The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
研究类型
介入性
注册 (实际的)
184
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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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins Bayview 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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Type 2 diabetics
- Age > 21 and ≤ 75 years
Exclusion Criteria:
- Inability to consent or commit to the required visits
- Use of insulin or other injections for diabetes
- Weight change of 10% in last six months
- Use of oral steroids in the last six months
- Pulmonary disease (i.e., COPD)
- Renal or hepatic insufficiency
- Recent MI or stroke (< 3 months)
- Sleep-related hypoventilation
- Obesity-hypoventilation syndrome
- Morbid Obesity
- Occupation as a commercial driver or operator of heavy machinery
- Active substance use
- Untreated thyroid disease
- Pregnancy
- Any history of seizures or other neurologic disease
- Poor sleep hygiene or sleep disorder other than sleep apnea
- Central sleep apnea
- Variants of obstructive sleep apnea (e.g., REM-related OSA)
- Participants not suitable for the study based on the clinical judgment
- Use of any investigational drug within the past 30 days
- Participating in another study
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 |
|---|---|
|
有源比较器：REMStar Positive Airway Pressure
Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
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Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
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其他：LifeStyle Counseling
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
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Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
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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 |
|---|---|---|
|
Change in Continuous Glucose Monitoring System Standard Deviation
大体时间：Baseline and 3 months
|
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
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Baseline and 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Difference in Systolic Blood Pressure
大体时间：Baseline and 3 months
|
Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.
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Baseline and 3 months
|
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Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
大体时间：Baseline and 3 months
|
Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group.
The outcome reported is the Reactive Hyperemic Index (RHI).
The RHI is a measure of endothelial vasodilator function.
The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded.
Persons with worse endothelial function have a lower RHI score.
Consequently, a low RHI indicates more endothelial dysfunction.
A value of 1.67 or less is considered abnormal vascular tone.
The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.
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Baseline and 3 months
|
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Heart Rate Variability
大体时间：3 months
|
3 months
|
|
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Change in the Epworth Sleepiness Scale
大体时间：Baseline and 3 months
|
The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness.
The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness.
A cut-point of ≥ 11 is also sometimes used to differentiate those with pathological sleepiness (≥ 11) versus those without < 11.
The difference between the three month final visit - the baseline visit score is reported by group
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Baseline and 3 months
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Change in Post-Pre Meal Blood Glucose Levels
大体时间：Baseline and 3 months
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The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal).
Data is presented for breakfast, lunch, and dinner.
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Baseline and 3 months
|
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Change in Glycosylated Hemoglobin A1c Level
大体时间：Baseline and 3 months
|
Change in point-of-care hemoglobin A1c (%) after three months.
|
Baseline and 3 months
|
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Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
大体时间：3 months
|
Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).
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3 months
|
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Continuous Glucose Monitoring System Standard Deviation
大体时间：3 months
|
The standard deviation of the glucose from continuous glucose monitoring at three months.
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3 months
|
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Change in Continuous Glucose Monitoring System Mean Glucose
大体时间：Baseline and 3 months
|
Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.
|
Baseline and 3 months
|
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：Naresh M Punjabi, MD, PhD、Johns Hopkins University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2014年12月1日
初级完成 (实际的)
2020年3月15日
研究完成 (实际的)
2020年3月15日
研究注册日期
首次提交
2015年1月14日
首先提交符合 QC 标准的
2015年5月26日
首次发布 (估计)
2015年5月27日
研究记录更新
最后更新发布 (实际的)
2021年5月25日
上次提交的符合 QC 标准的更新
2021年5月3日
最后验证
2021年5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.