Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
2014年6月16日 更新者：Bangor University
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.
研究概览
地位
完全的
条件
详细说明
Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation.
Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important.
This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.
研究类型
观察性的
注册 (实际的)
66
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
-
-
Gwynedd
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Bangor、Gwynedd、英国、LL57 2PW
- Betsi Cadwaladr University Health Board
-
-
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
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Mild to severe recently diagnosed Obstructive Sleep Apnea patients selected by physician who have not received any treatment for their condition.
Selected from Ysbyty Gwynedd in North Wales.
描述
Inclusion Criteria:
- Body Mass Index ≤39
- Not received any treatment for Obstructive Sleep Apnea.
- Is a non-smoker
- Is not epileptic
- Epworth Sleepiness Scale ≥ 10.
- Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.
Exclusion Criteria:
- Body Mass Index ≥ 39.
- Presence of significant or unstable Renal, Liver or Heart Failure.
- Receiving anti-diabetic treatment.
- Is a smoker.
- Is epileptic
- Presence of significant or unstable psychological morbidities.
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
队列和干预
团体/队列 |
|---|
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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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 |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
大体时间：one night within four weeks of study.
|
AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
|
one night within four weeks of study.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Residual volume
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Volume of air remaining in lungs after full expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Functional residual volume
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Air present in lungs at the end of passive expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Total lung capacity
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Total volume of lungs
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced Vital capacity
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs following a full inspiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced expiratory volume in one second (FEV1)
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs in one second.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Airway Resistance
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Opposition of flow caused by forces of friction.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Plasma 2-arachidonoylglycerol (2-AG)
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
Ligand of the G-protein coupled CB1 and CB2 receptors, has been found to be correlated with Oleylethanolamide (OEA) in OSA patients have various effects on energy metabolism.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
|
Plasma Anandamide (ANA)
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Ligand of the G-protein coupled CB1 and CB2 receptors, found to be correlated with blood pressure in OSA after the adjustment of confounding variables.
Have various effects on energy metabolism.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma oleoylethanolamine (OEA)
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma Leptin
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma Adiponectin
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma C-reactive Protein
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Marker of inflammation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Insulin
大体时间：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Neck circumference
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Waist circumference
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Hip circumference
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Weight
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Fat-free mass
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Fat mass
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Fat components of the human body estimated non-invasively using bioimpedance measurement system.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Maximal Inspiratory pressure
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Rate of inspiratory muscle fatigue
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
The decline in maximal inspiratory pressure following inspiration against a resistance.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Chest RPE
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Dyspnea
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Rating of breathlessness half way through fatigue protocol and at the end of protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 25% O2/ 6% CO2
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2 / 6% CO2
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Mean RR interval
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: Average time interval between the heart beats R waves
|
Within four weeks of recruitment prior to CPAP treatment
|
|
SDNN
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The standard deviation of all RR intervals
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 count
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 of total HR (%)
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: NN50 count divided by total number of all RR intervals.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
HRV triangular index
大体时间：Within four weeks of recruitment prior to CPAP treatment
|
The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Low frequency domain
大体时间：Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
High frequency domain
大体时间：Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
LF/HF ratio
大体时间：Within four weeks of recruitment prior to CPAP treatment.
|
The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
|
Within four weeks of recruitment prior to CPAP treatment.
|
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：Christopher MN Earing, MSc、School of Sport, Health and Exercise Sciences, Bangor University
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
2011年11月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2011年11月24日
首先提交符合 QC 标准的
2011年11月24日
首次发布 (估计)
2011年11月29日
研究记录更新
最后更新发布 (估计)
2014年6月17日
上次提交的符合 QC 标准的更新
2014年6月16日
最后验证
2014年6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.