SleepCheck, page-44

A great question. Thank you for your genuine interest in researching SleepApp. Genuine enough to pay $8 to download the app which speaks volumes.

Sleepcheck is approved as a class I device. It's used for screening, not diagnosis. It's used to screen for obstructive sleep apnoea (OSA), not central sleep apnoea. It does not replace to need for gold standard test in the diagnosis of OSA, which is, and will remain, in lab sleep study. Sleepcheck does not replace medical advice.

There is some misconception here, and elsewhere, that if a screening test cannot replace the gold standard test, than there is no value in having the test at all. Can I reiterate that this is false logic.

Cheap, easily accessible, non-invasive, user friendly screening tests have a vital role to play in discovering important and deadly diseases in our society, some of which would otherwise go undiagnosed and untreated, resulting in tragic health consequences, and sometimes death.

If you are old enough (>50 years old), or unfortunate enough to have a family history of breast cancer, you'd know the value of 2 yearly mammography for breast cancer screening. You would also be aware of the faecal occult blood tests, sent by the government to everyone over 50 years old, every 2 years, to screen for bowel cancer. These tests are not as cheap, nor as accurate, nor as user friendly, nor as scalable as Sleepcheck, but they are much cheaper and less invasive than the gold standard tests for breast and bowel cancer (ultrasound guided biopsy and colonoscopy+biopsy respectively for these cancers), and so the tests are applied to whole at-risk populations, by the government. These tests, despite having accuracies of only 60-70% (compared to Sleepcheck of 90%), have saved numerous lives. They have been enormously successful, and form the foundation in reducing morbidity and mortality caused by these two cancers.

Signficant parallels can be drawn between the value of screening for OSA and that for breast and bowel cancers. OSA affects a signficant portion of our population (4-6% of general population, up to 38% in older male age group), and remains hugely underdiagnosed. It's a signficant cause of morbidity and mortality (think of all the workplace and road accidents when undiagnosed / untreated cases of OSA falling asleep during the day). There is clearly a desperate need for whole at-risk population screening, much like breast cancer and bowel cancer. Until we had Sleepcheck, there has been no satisfactory way of screen for OSA, the only alternative being home sleep study which is not an option as it's expensive and very difficult to use. Now with Sleepcheck, we have a cheap, accurate, scalable, non invasive, user friendly screening tool for OSA, the barrier for screening will be demolished and hopefully underdiagnosis of OSA will soon become a thing of the past, much like undetected, late-stage, deadly breast and bowel cancer cases have become much rarer with the advent of mammography and faecal occult blood tests.

Finally, to your concern about the presence of a disclaimer, this is obviously necessary for the legal protection of RAP. It's standard practice, and it's pointing out the obvious, that lay people should not attempt to interpret medical test results without medical input. Medical science is a difficult thing indeed, and we mustn't assume that any one test will give us the answer, or the cure, to your problem. Indeed, implicit to any good medical practice, doctors should acknowledge that no test and diagnostic decision are ever 100% accurate. Any test results, or decisions, must be interpreted in the whole context of the disease and patient's situation, with appropriate follow up and safety net put in place. Indeed, that's why we have doctors, and not machines, to see and manage diseases!

I hope I haven't been too cryptic in my response to your questions. Feel free to comment and ask further questions if you are still concerned.