Case Study: sleep apnoea（睡眠呼吸暂停）在线视频

Sleep Apnoea

睡眠呼吸暂停

This project is instantaneous effect of meridian point stimulation on managing sleep apnoea.

本课题是经络穴位刺激治疗睡眠呼吸暂停的瞬时效应。

This is the content.

这是课题的内容。

What is sleep apnoea?

什么是睡眠呼吸暂停呢?

Sleep apnoea is cessation of breathing for more than ten seconds during sleep. It can be classified as obstructive, central and mixed.

睡眠呼吸暂停是指在睡眠中停止呼吸超过10秒，可以分为阻塞型、中心型和混合型。

Prevalence is around 2-4% of adult population with male predominance.

成年人的患病率约为2-4%，并以男性患者为主。

Negative consequences of sleep apnoea are daytime sleepiness, cognitive dysfunction and memory loss, traffic accidents, and it may link to cardiovascular diseases.

睡眠呼吸暂停的负面影响包括白天嗜睡、认知功能障碍和记忆力丧失、交通事故，还可能导致心血管疾病。

Current Management Methods.

目前的管理方法有

Patients usually use CPAP machines, but they need to put on a mask during sleep. So most of the patients, they complain of experience of discomfort.

患者通常使用睡眠呼吸机，但他们需要在睡觉时戴上口罩。所以大多数患者会抱怨感觉不舒服。

The doctors may also ask the patients to lose their weights, or they change their sleeping positions. These methods are rather conservative.

医生也可能要求患者减肥，或者改变他们的睡姿。这些方法相对来说比较保守。

So our research aims is to investigate the efficacy of applying a new approach in order to manage symptoms of sleep apnoea. This new approach will apply instantaneous meridian point stimulation in response to the occurrence of a sleep apnoea episode.

因此，我们的研究目的是探讨应用一种新的方法来控制睡眠呼吸暂停症状的有效性。这种新方法将在睡眠呼吸暂停发作时瞬时刺激经络穴位。

What are the research questions?

那么研究的问题是什么呢?

The first one is to identify a critical physiological signal. The first question is what is the critical threshold of using these signal?  If we find the signals, which meridian point should we use in order to trigger the intervention and make them restore the breathing?  Is meridian point stimulation able to manage symptoms of sleep apnoea immediately? Will there be different if I make a stimulation on meridian point or just any other points?

首先是要识别出一个关键的生理信号。那么第一个问题是使用这些信号的关键阈值是多少?如果我们发现了这些信号，我们应该触发哪个经络穴位来让患者恢复呼吸?经络穴位刺激能立即控制睡眠呼吸暂停的症状吗?如果我刺激经络穴位或者任意其他穴位会有什么差别吗?

In this study,we will try to investigate all these.

所以在这项研究中，我们将尝试解决所有这些问题。

Research Design - This research was divided into two parts. The first part is to identify a critical signal. And the second part is to evaluate the efficacy of meridian point stimulation for managing symptoms of obstructive sleep apnoea.

研究设计 - 本研究分为两部分。第一部分是识别出一个关键信号。第二部分是评价经络穴位刺激治疗阻塞性睡眠呼吸暂停症状的疗效。

In the first study we invited 10 subjects. We tested their pulse oximetry level, the phase relationship of thoracic and abdominal signals and also we measured their mean absolute amplitude of thoracic and abdominal signals.

在第一部分研究中，我们邀请了10名研究对象。我们测试他们的脉搏血氧饱和度，胸腹信号的相位关系及他们胸腹信号的平均绝对振幅。

For the second study, we conducted a pilot and main test. The pilot one was to test the feasibility and smoothness of the experiment. While the second part, the main test is to evaluate the efficacy of meridian point stimulation for managing symptoms of sleep apnoea.

对于第二部分研究，我们进行了先导和主体研究。第一先导研究是测试实验的可行性和顺利性,第二主要研究是评价经络穴位刺激治疗睡眠呼吸暂停症状的疗效。

The first study, which signal should we use? Traditionally, we use nasal airflow sensor to measure the airflow of the patients. We need to put the sensor underneath the nose. But as we know, it may produce discomfort and also irritate the users. So we need to explore the possibility of using alternative signal.

第一部分研究，我们应该使用哪个信号呢？习惯上，我们会使用鼻腔气流传感器来测量患者的气流。我们需要把传感器放在鼻子下面。但如我们所知，它可能会产生不适感并烦扰使用者。所以我们需要探索使用其他替代信号的可能性。

The possible critical signals based on the literature are pulse oximetry level, the phase relationship of the thoracic and abdominal signals, and the amplitude of the thoracic and abdominal signals.

根据文献，可使用的关键信号有脉搏血氧饱和度、胸腹信号的相位关系及胸腹信号的振幅。

So the aim of this part is to see whether the promptness and the accuracy of using the above three signals would indicate sleep apnoea.

因此，这部分研究的目的是检验出使用上述三种信号提示睡眠呼吸暂停的快速性和准确性。

We invited subjects to the sleep laboratory for one night. We measured their sleep apnoea by measuring their pulse oximetry level, the first one, the second and the third signals. Finally 10 male subjects were recruited with age around 47 and BMI was around 27 and the apnoea index. Apnoea index is the number of apnoea per hour. It was around 46.

我们邀请研究对象到睡眠实验室住一晚。我们通过测量他们的脉搏血氧饱和度,第一个，第二个和第三个信号来评估他们的睡眠呼吸暂停症状。最后，招募了10名男性研究对象，年龄在47岁左右，BMI在27左右和呼吸暂停指数在46左右。呼吸暂停指数是每小时呼吸暂停的次数。

The first parameter was pulse oximetry of level. We need to measure the time difference between the onset of nasal airflow, cessation and also pulse oximetry level met the 4% oxygen desaturation from the baseline level.

第一个参数是脉搏血氧饱和度，我们需要测量鼻气流开始、停止和脉搏血氧饱和度与基线水平相比达到4%之间的时间差。

The results we had recruited ten subjects. Each subject has around 50 sleep apnoea events well recorded.  The overall time difference between the onset of nasal, cessation of nasal airflow and the decrease of 4% SpO₂ level was around 22 seconds.

结果是，我们招募了10名研究对象，每名研究对象都有50次左右的睡眠呼吸暂停事故。鼻部气流开始、停止和血氧饱和度下降4%的整体时间差约为22秒。

Because these signals produced very long time difference, so we did not select it.

因为这些信号产生很长的时间差，所以我们没有选择它作为指标。

The second one was to study the phase relationship between the thoracic and abdominal signals.

第二个是研究胸腹信号的相位关系。

As you may see, there are two pictures. The picture on the left is the person with normal breathing. The signal is abdominal and thoracic. They are almost the same phase. But the right one, you will see, when the patients have experienced airway obstruction, they have different phase. We measure this phase and test the phase stability by using ROC curve. We found that the performance was not satisfactory.

你们可以看到，这里有两张图，左边的图是呼吸正常的人。这是胸部和腹部的信号，它们几乎处于同一相位。但是在右边的图，你会看到，当患者有气道阻塞时，他们是不同的。我们用ROC曲线来测量这个相位和相位稳定性，我们发现结果并不令人满意。

And then finally we chose to study the mean absolute amplitude of the thoracic and abdominal signal. Here we measured the mean absolute amplitude of the thoracic signals, abdominal signals, and combination of both.  The method we used was Piezo Respiratory Effort.  We selected the cut-off value and we did the ROC analysis.

最后我们选择研究胸腹信号的平均绝对振幅。这里我们测量了胸部信号、腹部信号及两者结合的平均绝对振幅。我们使用呼吸压力传感器，然后选择临界值，最后做ROC曲线分析。

The cut-off value here is. The optimum is -25%. And we found that using ROC test. The combination of thoracic and abdominal signal achieves the overall good performance.

这个是临界值，我们用ROC检验发现最佳值是-25%，而结合胸腹信号分析可达到整体良好性能。

The second study is to evaluate the efficacy of meridian point stimulation for managing symptoms of obstructive sleep apnoea. We had a pilot study and main study.

第二部分的研究是评价经络穴位刺激治疗阻塞性睡眠呼吸暂停症状的疗效。我们有先导和主体研究。

We recruited three subjects, two subjects with the obstructive sleep apnoea, and one with mixed sleep apnoea.  We used snore stopper which is a device to stimulate the Neiguan meridian point of patients.

最后我们招募了三个研究对象，其中两个研究对象为阻塞性睡眠呼吸暂停，另一个为混合型睡眠呼吸暂停。我们使用止鼾器装置来刺激患者内关穴。

Then the subjects, they underwent two nights of study, one baseline and one intervention study. In this study, there were three levels of stimulations. These are the specifications.

然后研究对象经历了两晚的研究。一个基线研究和一个干预研究。在这项研究中，有三层次的刺激。这些是详细说明。

The results are the intended outcome parameters were successfully measured. We found that the patients were aroused,or sometimes they didn’t wake up to the stimulation. So we need to carefully calibrate the stimulation to avoid patients being aroused during sleep.

结果显示我们能成功测量预期的效果参数，我们发现患者有时是被刺激醒过来，但亦有时没有。因此我们需要仔细校准刺激，以避免唤醒在睡眠中的患者。

So based on this pilot study, we had recommendations for the main study. It’s that the stimulation intensity should be adjusted. We had to increase the choice of the level of intensity, and also to ensure good sensitivity of the signals.

所以在这个先导研究的基础上，我们对主体研究提出了建议，刺激强度需要调整。我们必须增加刺激强度的选择，同时还要保证信号的良好灵敏度。

After the pilot study, we conducted main study. The method was a single-blinded randomized controlled trial. We studied the pre-post effects of the intervention. Subjects needed to come and had two nights of sleep study with one baseline and one test study.

先导研究后，我们进行了主体研究。方法为单盲随机对照试验。我们研究干预前后的效果。研究对象需要参加两个晚上的睡眠研究，一个是基线研究，另一个是测试研究。

We divided the subjects into three groups. One group was the subjects received meridian point stimulation, one group received sham that means non-meridian point stimulation, and one control group that means without any stimulations. There were 27 subjects in total, with 9 subjects in each group.

我们把研究对象分成三组，一组是研究对象接受经络穴位刺激，一组接受假干预也就是非穴位刺激，另一组没有接受任何穴位刺激的对照组。总共27名研究对象，每组9名。

The recruitment method was convenience sampling. We used random drawing to divide them into groups.  The inclusion criteria were aged between 18 and 65 with apnoea index large than 5 in the baseline study. The exclusion criteria were pregnant, mentally ill, using pacemakers, have a history of obstructive lung diseases, severe skin diseases, or had meridian point therapy 3 days before the test.  We chose LU7，Lieque, the point for the stimulation in this project.

招募方法为方便抽样，我们用方便抽样方法把他们分组。纳入标准年龄为18 ~ 65岁，同时基线研究时呼吸暂停指数需大于5。排除标准为孕妇、精神病患者、使用起搏器者、有阻塞性肺疾病病史者、严重皮肤病者、或在测试前3天进行过穴位治疗者。我们选择LU7，列缺为这项研究的刺激穴位点。

In the baseline study, we only recorded the physiological signals of the subjects.In the intervention study, the subjects were required to record the signal and plus interventions.  The intensity of stimulation could be adjusted during the sleep study.

在基线研究中，我们只记录了研究对象的生理信号。在干预研究中，研究对象需记录信号和干预措施。在睡眠研究中，刺激强度是可以调节的。

This is the LU7 points, the Lieque Meridian point.  The meridian point is in the lower arm.

这是LU7点，列缺穴。这个穴位位于前臂上。

This picture shows the patients we used polysomnography (PSG) to measure their physiological signals, and at the same time, we provided electrical shock unit to see how they react during sleep apnoea. When there is starting of sleep apnoea, after ten seconds the stimulation will be released for eight seconds.

这张图展示了我们使用多导睡眠图来测量患者的生理信号，同时我们也提供电击装置，以便观察他们在睡眠呼吸暂停时的反应。当睡眠呼吸暂停出现10秒钟后，装置便会释放出持续8秒的刺激。

These are results.  Among 27 subjects with obstructive sleep apnoea,there were 25 male subjects and 2 female subjects. The mean age was 45, the baseline BMI was 27 and the baseline AI (apnoea index) was 30.

这是27名患有阻塞性睡眠呼吸暂停的研究对象的研究结果。男性25名，女性2名。研究对象的平均年龄为45岁，基线BMI为27，基线呼吸暂停指数为30。

You may see, apnoea index for subjects with meridian point stimulation decreased more than the subjects in sham group and also control group; same also for the apnoea-sleep ratio, average apnoea duration, average desaturation level, average number of respiratory arousal, and percentage of deep sleep.

正如你可以见到，经络穴位刺激组研究对象的呼吸暂停指数比假操作组和对照组下降得更多。同样的还有呼吸暂停的睡眠比例，平均呼吸暂停时间，平均去饱和度，平均呼吸唤醒次数，以及深度睡眠的百分比。

We found that the patients with meridian point stimulation achieved the best results as compared with other groups. We also used one way ANOVA to test. We found there was no significant difference.

我们发现经络穴位刺激组与其他组相比效果最好。我们还使用了单向和反向测试，但发现并没有显著的差异。

For the trend, pulse oximetry level is consistently higher over the entire study in the second night than the first night in the meridian point stimulation group.  The trend of heart rate produced the same results.

在整个研究过程中，穴位刺激组在第二晚的脉搏血氧饱和度一直高于第一晚。心率的变化也产生同样的趋势。

We found that Immediate change effected on the change of the pulse oximetry level. The patients with meridian point stimulation, they have quickly restored their pulse oximetry level after their meridian point stimulation than the sham group.

我们发现这立即改变了脉搏血氧饱和度的变化，。经经络穴位刺激的患者，在穴位刺激后脉搏血氧饱和度相比假操作组能迅速恢复。

Based on these results, we found that in this study the majority of subjects were male, around 90% of subjects.  They were diagnosed as sleep apnoea but only 55% of subjects continued the CPAP treatments.

基于这些结果，我们发现在这些研究中，大多数研究对象为男性，大约90%的研究对象。他们被诊断为睡眠呼吸暂停患者，但只有55%的研究对象继续接受CPAP治疗。

For the meridian point stimulation group, they tended to have stronger needs, stronger intensity to stimulate them.  We need to consider also whether the subjects will arouse during sleep or not, and this will be the most important issue.

而对于穴位刺激组，他们往往有更强的需求和需更强的刺激强度。所以我们也需要考虑研究对象是否会在睡眠中被弄醒，这些将是最重要的问题。

Conclusions - Finding for research question 1 is that the mean absolute amplitude of thoracic and abdominal signals with around 0.8 ROC value achieved the best results in this study.

研究问题1的结论和发现是，以ROC值在0.8左右的胸腹信号的平均绝对振幅在这个研究中是最佳的结果。

We used -25% as a cut-off point, and we decided to stimulate the Leique meridian point of patients.

我们用-25%作为临界点，并选择刺激患者的列缺穴。

We have found that meridian point stimulation reduced apnoea index, apnoea-sleep ratio and average apnoeic duration but not really significant for improving sleep quality. We also found that managing effect using meridian point stimulation in terms of the respiratory events and sleep quality was better than the non-meridian point.

同时，我们发现经络穴位刺激降低了呼吸暂停指数、呼吸暂停睡眠比和平均呼吸暂停时间，但对改善睡眠质量却没有实际意义。我们还发现经络穴位刺激对呼吸事故和睡眠质量的管理效果优于无穴位刺激。

The clinical implications were that there was no adverse effect produced, such as skin irritation, nausea. The Impact which we need to further study whether the impact of stimulation on the EEG or it may cause arousal to the patients. We need to provide the intervention at appropriate time that is really crucial in this project.

在临床应用，没有副作用产生，如皮肤刺激，恶心。但是我们需要进一步研究刺激对脑电图的影响，或可能这还是会引起患者的觉醒。在这个项目中尤为关键的是，我们需要在适当的时候启动干预。

This is the prototype our team had developed. And you may see, the belt which is used to measure physiological signals, that is, abdomen and thoracic signals of the subjects. It means that they need to put on this when they sleep, and at the same time, they need to wear the wrist band. This wrist band will have a smart material on it. In case it detects the cessation of breathing of the patients, the wrist band will release the electrical stimulation on the LU7, the Leique point of patients.

这个是我们团队开发的原型。你可以看到，这个皮带是用来测量生理信号的也就是研究对象胸部的信号。因此这意味着他们需要在睡觉时戴上这个，同时，他们需要戴上腕带。这个腕带将有一个智能材料在上面，如果它测试到患者呼吸停顿，腕带会释放电刺激患者的列缺穴。

We currently licensed it to the AdvancePro, and got the USA patent in 2007.

我们目前授权给AdvancePro生产，在2007年获得了美国专利。

These are our publications and the awards.

这些是我们发表的文献和奖项。

Thank you！

谢谢!