mHealth Clinical Trial Measures Sleep Outcomes

Adam Amdur, Chief Patient Officer of the Sleep Apnea Association launched the SleepHealth mobile app study, the first large-scale observational sleep study that leverages mobile health to collect real world data. Adam will elaborate on his experiences with the SleepHealth Study (available on the App Store), and the impact of mHealth in clinical trials.

Moe Alsumidaie: What inspired you to launch the SleepHealth mobile app study?

Adam Amdur

Adam Amdur: I am a big believer in technology and embracing the real-time bidirectional, connected world. As a patient advocacy association, we decided it was essential for us to adapt the SleepHealth platform for our community. We want to use technology to scale and broaden our message to patients. 

We saw that Apple’s Research Kit had tremendous enrollment outcomes by reinventing the recruiting/consenting mechanism to enroll a large amount of patients into clinical trials overnight, and we wanted to leverage our patient access to collect sleep apnea patient centered outcomes. We have reach to more than 350,000 patients through our online and social channels, including our website (www.sleepapnea.org), Facebook page, Linkedin Group, and active professionals including sleep specialists, dentists, cardiologists, endocrinologists, and diabetes experts, mental health experts, oncologists, neurologists, pediatricians, and even autism specialists in early childhood development. 

MA: Why was the SleepHealth App Developed?

AA: There is a sleep component that we all do in every day of our lives; in fact, it’s something that we do for a third of our lives. Sleep deprivation was overlooked in the medical world for far too long, and it is changing. That behavior change is what led us towards coming up with a research kit that is not only sleep-disease focused but contains a sleep preventative health focus. Everyone is up to speed on exercise and nutrition and in movement. We want sleep to become the third pillar in the health and prevention world.

We feel that by launching our research kit, we not only want to look at all the unhealthy sleepers in the world, but we also want to look at the healthy sleepers so that we can finally show what good healthy sleep does for an average everyday person and what happens when you do not get sleep, even if you don't have the disease, how it’s affecting your life. Sleep affects your cognitive alertness, mood, productivity, performance on the playing field, classroom and work. It affects the quality of your relationships at home, your marriage, children and parents. We now have a society that is dependent on caffeine and energy drinks that are constantly trying to fix the shortcomings of poor quality sleep or some sort of deprivation. I always tell people, it’s not only how many hours of sleep you need, but what kind of hours. It needs to be good sleep. It can’t be interrupted. You can’t be on your phone. The temperature in the room needs to be cooled down, it can’t be polluted. We have to try to do everything in our power to get back to the world that was pre-electricity where our bodies biologically reacted and knew when to go to sleep and when to wake up. We do not have that anymore, so we need to learn to adapt to that.

MA: Who is eligible for the SleepHealth Study? Can you describe the study’s design and ultimate objectives?

AA: The SleepHealth Study is a prospective observational study. Everybody in the world is encouraged to participate. Right now it is available for ages 18 and older. Our next version is to target a younger age, because we feel that younger kids, especially teenagers, are more adept to participating on iPhones and mobile devices. By conducting long term measurements, we can change their behavior pattern in their teen years when their biological clock and their circadian rhythms are really changing. We can help educate them now. We believe that in the long-term we will wipe out most of the comorbidities that are plaguing our society today. So these millennials are important and generations coming after these millennials is even more important because technology is all they know. 

We are collecting passive data from the iPhone, and heart data from the iWatch. In the future, we plan on using the iWatch in the workout mode, so that patients can wear the watch at night during sleep and collect heart rate data every five seconds. 

We have self reported questions we are asking, and are looking at the passive data coming in from their iPhone and iWatch. We have not brought in any other devices because we feel that it’s really important to start to educate the public about all the sleep data that they think they are getting, which we know is not necessarily accurate or objective. We have given people the opportunity to participate with their sleep diaries for seven days and will reissue those quarterly.

MA: What are subjects’ experience with taking Patient Reported Outcomes surveys via mobile platforms?

AA: We have an alertness measurement everyday when subjects receive random notifications if they want to participate, and have a PVT (Psychomotor Vigilance Test) that tests your alertness. However, people have complained that this 3 minute questionnaire takes too long); Apple iWatches are designed and programmed to enable  people to glance at it for a few seconds, not fill our surveys for 3 minutes. So there’s a behavioral shift going on in society that is mixed with the changes in technology, and we are embracing it.

MA: How will you be able to detect sleep patterns through limited wearables functionality, such as heart rate?

AA: We are working with a group called Cardiogram that is doing research for atrial fibrillation by looking at major data with the Healthy Heart Alliance at UCSF. We are in the early stages of figuring out what the data is going to show us, but basically if we get heart rate data every five seconds on participants, 24X7X365, that is more heart data in a public health study than we've ever had in the history of time, and that can certainly contribute towards detecting sleep patterns, such as apnea, and sleep cycles. We think we can find an algorithm that will help us, at least as an early detection or as an early warning; not necessarily as a diagnosis, but more as a risk prevention measure. As the Apple watch opens up, we think we can potentially take other sensors and other features of the watch like the heart rate, skin temperature, and oximeter (which Apple has not yet confirmed, as rumor says they seem to be having problems with it). 

We can now take measurements with three variables; if we have four variables, oxygen, heart, skin temperature and actigraphy that would give us four out of the five major variables to match up to what will be considered the gold standard of objective sleep measure, which is a full PSG (Polysomnographic study) inside a lab. There are some startups that are work on wearable innovations; there are wireless EEG leads on the forehead that measure brain activity which is the other way of really confirming what stages of sleep patients are getting.

MA: Can the ‘Mobile App’ sleep measurement system be used in clinical trials to measure sleep outcomes?

AA: Absolutely, The last thing people do before they go to bed is to look at their phone and the first thing they do when they wake up is to look at their phone. Moving forward, there is no doubt that this should be right in the middle of the heart of every clinical trial that goes on traditionally or non-traditionally, as sponsors can collect very detailed sleep outcomes data from patients. Sleep has got to become a vital sign as one of the things we are advocating for. Just like when you go to your primary care and they check for your heart rate and they look in your mouth, we are trying to make sleep a vital sign.

The BYOD approach has been very successful with adoption, since it is so easy and diffusible with patients. While many argue that not everyone has an Apple phone, we disagree; we have been able to access and enroll patients so rapidly. You can look at our demographic data and see how many people across the globe are using Apple phones. We plan to also deploy the SleepHealth Study app on Android devices to further expand our reach.