Wearable Sleep Apnea Device

About this project: 

Sleep apnea is a tough medical condition that can lead to serious health issues for people who suffer from it. Unfortunately most sleep apnea treatments are also heavily disliked by most patients. This project's goal was to uncover and develop a novel treatment to sleep apnea. 

Contribution:

I was the lead engineer and project manager on this project working in tandem with the CEO, a medical advisor, and one other part time engineer. I started working on this project at the very beginning and took it through early clinical trials. 

Requirements and Challenges

The main goal of this project was to identify if there are other ways to mechanically open the throat during sleep so that sleep apnea sufferers could once again enjoy uninterupted sleep. However, in order to achieve this our device would also need to be very comfortable, stay in place all night, fit all different shapes and sizes of people, and meet all FDA regulations. 

Brainstorming and Prototyping

We began by conducting multiple brainstorms including our medical experts and industrial design team to come up with as many ideas as possible. To quickly test our ideas we then converted 10+ of our ideas into dead simple prototypes to see what had merit. 

Quick and *Clean* Testing

Since clinical sleep testing of prototypes would have been slow and expensive we needed to come up with a cheaper and faster way to test out our early stage prototypes. Of course, since this testing would need to be done on humans we also needed the testing to be as clean and harmless as possible. We eventually found an old technology that was able to measure throat inner diameter. We used this device to test our large array of prototypes on humans in a matter of minutes. Coming out of this we were able to identify the prototype that had the highest efficacy. 

Refinement

We then went through a phase of refinement of the fitment, sealing, and comfort of the device. We built several rounds of prototypes, each targeted at a specific problem that we were trying to solve for. Once we had identified solutions to each of the individual problems we then rolled that into one design that was ready for the big leagues: clinical trials. 

Clinical Trials

The device was then overnight tested at a sleep center on about 20 patients. Over 80% of the patients showed an improvement of their sleep apnea symptoms and the majority of patients actually saw their condition completely resolved. Overall the trial was a huge success for a first study and the business was ready to move to the next stages. However, commercial development of this project is currently paused.