Innovative home testing platform offers new hope in sleep apnoea diagnosis
A North American digital health company is looking to extend the commercial reach for its pioneering diagnostic platform, developed to identify patients suffering from a potentially fatal sleep disorder common among older adults.
Chicago-headquartered Sibel Health received US Food and Drug Administration clearance in July 2022 for its ANNE Sleep tool created to help doctors detect patients suspected of having moderate to severe cases of obstructive sleep apnoea.
The team behind the wearable appliance then launched it with select commercial partners, following clinical research that showed ANNE Sleep could single out most moderate to severe sleep apnoea cases with a lower number of false positives compared to the current gold standard polysomnography (PSG) test.
Now Northwestern University spinout Sibel Health is planning to make the technology more widely available as a way for clinicians to monitor patients’ vital signs in real-time.
Obstructive sleep apnoea affects more than a billion people worldwide and can happen to anyone from children to adults. However, it is a significant issue among older adults with up to 32% of over 65s thought to have some form of sleep apnoea, according to the European Respiratory Society.
The condition results from the upper airways becoming blocked while a person sleeps, which can reduce or stop airflow. As a result, people with obstructed airways can wake up multiple times throughout the night, leading to them feeling excessively tired during the day and suffering from headaches.
Sibel Health’s ANNE Sleep tool created to help doctors detect patients suspected of having moderate to severe cases of obstructive sleep apnoea.
But undiagnosed and untreated obstructive sleep apnoea can have far more serious implications, including the risk of developing high blood pressure, type 2 diabetes, strokes, and heart attacks, and in the worst cases a shortened lifespan.
Whilst anyone can develop obstructive sleep apnoea, being overweight, having high blood pressure, chronic nasal congestion, a naturally narrowed airway, smoking, asthma or diabetes, may put someone more at risk.
Men are two to three times more likely than premenopausal women to have obstructive sleep apnoea. However, the chance of contracting it increases in women after menopause.
The risk of obstructive sleep apnoea also grows with age, although it appears to level off after your 60s and 70s. A family history of sleep apnoea may also play a part.
Yet around 90% of cases remain undiagnosed.
As Ha Uk Chung, vice president of research and development and a co-founder of Sibel Health, explained, obstructive sleep apnoea isn’t just a disorder, it is a “silent health crisis. Most people don’t know they have it.”
ANNE Sleep has originated from prior FDA-endorsed devices Sibel Health created for tracking a person’s cardiorespiratory metrics, including their heart and breathing rate, body temperature, and oxygen saturation levels for premature babies.
Dr Chung revealed they had a specific vision in mind. Since at-home tests for sleep apnoea can include multiple wires, chest bands, and breathing tubes, which can be both cumbersome and uncomfortable when you’re trying to get a good night’s rest, the award-winning medical technology company set out to create a flexible, wearable system.
Ha Uk Chung, vice president of research and development and a co-founder of Sibel Health.
He revealed they wanted something that would easily attach to the skin, collect a wide range of data, be easy to use, not interfere with a person’s natural sleep, could be used for multiple nights if required, and be cost-effective.
ANNE Sleep uses two wireless sensors to track a person’s sleep patterns. One attaches to the skin on the chest, the other clips onto the index finger.
A person wears both sensors before they go to sleep. The sensors then measure their total sleep time through an artificial intelligence (AI) algorithm. The sensors also measure their heart rate, snoring, blood oxygen saturation, and body position among other factors.
After the person wakes, they charge the sensors, which upload the collected data into a secure hub.
A qualified physician can then assess the patient’s sleep patterns based on one or multiple nights.
If a person has at least five breathing interruptions during an hour of sleep due to fully or partially blocked airways, then they are classed as having mild obstructive sleep apnoea.
Moderate forms occur when the airways are blocked at least 15 times. Severe forms start at 30.
An adult needs at least seven hours of sleep each night to support the body’s many functions. If a person is constantly waking up due to interrupted breathing, the ensuing sleep deficit can significantly impact their health.
So, the earlier an individual can be screened, diagnosed, and treated for obstructive sleep apnoea, the better.
The methods for treating obstructive sleep apnoea vary but may include mouthguards or devices such as continuous positive airway pressure machines, which deliver just enough air pressure to a mask to keep the upper airway passages open, preventing snoring and sleep apnoea.
A total of 225 adults suspected of having moderate to severe obtrusive sleep apnoea, took part in clinical research to see if the wearable system could accurately diagnose the disorder.
The team at Sibel Health wanted to see how close the ANNE Sleep device came to the polysomnography test, which records a patient’s brain waves, oxygen levels in the blood, and heart rate and breathing during sleep. It also measures eye and leg movements.
PSG is an overnight sleep assessment but is only conducted at either a laboratory or an accredited sleep centre. Its electric sensors attach to a person’s chest, eyelids, head, and chin so that researchers can make the necessary observations.
For the ANNE Sleep trial participants completed an overnight sleep assessment at one of four sites in Illinois in the midwestern United States. During the visit, each participant’s sleep was assessed by PSG while they wore the ANNE Sleep sensors.
Both PSG and ANNE Sleep identified about one-third of adults with moderate to severe forms of obtrusive sleep apnoea. The results showed the wearable device could identify most moderate to severe sleep apnoea cases with a low number of false positives compared to PSG.
After the trial, the participants completed a post-study survey. Most reported the system was easy to use and comfortable, and that they could see themselves using it again.
Dr Chung said: “User feedback is what motivates us.” He elaborated that thinking about how patients are using the system to support their health is what drives Sibel Health’s researchers to scale the technology.
The system is said to be suitable for all adults, but Dr Chung envisioned it would appeal to those with increased risks for obstructive sleep apnoea who would prefer to conduct overnight sleep assessments from the comfort of their own homes.
This might include adults aged 65 and older.
Stephanie Davis, a small business programme coordinator within the Division of Extramural Research Activities at the United States’ National Heart, Lung, and Blood Institute, which gave a grant to Sibel Health to support its work, said: “With obstructive sleep apnoea being a significant issue among older adults and for so many people in our population, it’s encouraging to see new devices for diagnosing and treating sleep apnoea
“It’s a great way to bring in new technologies that focus on an important unmet clinical need.”
