Specific HST Recommendations

With the potential to be more comfortable and easier to use than airflow-based HSTs, NICE states newer devices with fewer wires may facilitate more accurate sleep apnea diagnosis “because they allow a more natural night’s sleep.” Still, airflow-based technologies can be the best option for patients for whom extra data is needed, NICE writes, and clinicians may opt to add third-party oximeters to HSTs that lack them for people with comorbidities such as COPD.

“We are thrilled to see the recent NICE guidance recognizing the value of home-testing devices, including WatchPAT,” says Melih Alvo, senior director of commercial marketing at ZOLL Itamar. “This acknowledgment underscores the critical role that innovative, patient-focused solutions play in overcoming the barriers to diagnosis and improving access to care.”

Acurable AcuPebble SA100

NICE recommends the Acurable AcuPebble SA100, which uses a wireless sensor placed on the throat to record sounds generated from physiological body processes, including respiratory and cardiac functions.

“The NICE recommendation represents a breakthrough in sleep apnea testing and diagnosis and will rapidly cut patient waiting time,” says Esther Rodriguez-Villegas, PhD, CEO and founder of Acurable. “Our hope is that more patients will be diagnosed using AcuPebble, freeing up clinician time to focus on treatment and reducing the number of people who remain undiagnosed and at risk of more serious health complications.”

NICE used data from “Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study” to make its recommendation. That study found that AcuPebble SA100’s automated diagnosis matched that of a traditional airflow-based HST worn simultaneously when compared on four common parameters (apnea-hypopnea index at 3% and 4% desaturations and oxygen-desaturation index at 3% and 4% desaturations).

“Medical technology like AcuPebble has the power to create a more efficient healthcare system that benefits both patients and clinicians, and it’s exciting to see bodies like NICE endorsing such devices for at-home testing,” Rodriguez-Villegas says.

Sunrise

NICE recommends the Sunrise HST, which uses a wireless sensor placed on the chin to measure mandibular movement.

“We are delighted by this milestone, which is another validation of our commitment to build a robust body of evidence and highlights the meaningful impact Sunrise can have on both healthcare systems and patients,” CEO Martinot says.

NICE used data from “Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study” to make its recommendation. The real-world study found that Sunrise’s HST reduced the time to treatment decision by a third (19.5 days versus 13.5 days for Sunrise) and saved about 29 minutes of staff time per patient compared to a traditional airflow-based HST. “We are very pleased with this, and we believe it will further accelerate the adoption and benefit the clinician and the patient in the end,” says Fabien Crespo, director of growth and business development at Sunrise.

Chest physician Michael Polkey, an early adopter of Sunrise in his clinical practice, adds in a statement, “Sunrise’s inclusion in the NICE guidelines is a testament to the clinical utility and innovation of this technology.”

ZOLL Itamar WatchPAT 300/ONE

NICE recommends the WatchPAT 300 and WatchPAT ONE, the latest reusable and disposable, respectively, versions of ZOLL Itamar’s WatchPAT technology. The HSTs use a device-hub wrist strap and wired finger and chest sensors to measure a proprietary peripheral arterial tonometry signal, heart rate, oximetry, body movement and position, snoring, and chest motion.

Because WatchPAT 300 and WatchPAT ONE use identical algorithms and produce identical signals to the earlier WatchPAT 200U, NICE determined that technological continuity allowed the new devices to meet its efficacy standards. NICE also reviewed the study “Sleep position, patient comfort, and technical performance with two established procedures for home sleep testing,” which concluded that WatchPAT had fewer technical failures than traditional airflow-based HSTs and was perceived by participants to cause less discomfort and awakenings during testing.

“The inclusion of WatchPAT in the recommendations affirms its clinical accuracy, ease of use, and reliability as a diagnostic tool,” Alvo says.

NICE’s Other HST Guidance

Nomics Brizzy

NICE does not recommend Nomics Brizzy HST, which consists of a waist-belt device hub and wired sensors placed on the chin and forehead to measure jaw activity signals (“JAWAC”), including mandibular movement.

NICE concludes there was too much concern about the data surrounding the test’s accuracy because the estimates in the study “Mandibular movements as accurate reporters of respiratory effort during sleep: validation against diaphragmatic electromyography” were provided using cut-off values established in the same study, which would overestimate diagnostic accuracy.

“The timing of NICE’s guideline coincided with our ongoing development of Brizzy’s diagnostic capabilities, and we are actively addressing this gap through ongoing clinical studies in France and Spain, which will provide robust evidence to support Brizzy’s use as a diagnostic tool,” a Nomics medical advisor says via an emailed statement. “Brizzy is our type IV device, first developed as a ‘super screening tool’ leveraging the success of the JAWAC sensor….As a result, most published studies on Brizzy focus on its screening capabilities and fall outside the scope of NICE’s diagnostic assessment.”

Nomics also designed a type III Augmented Polygraphy Brizzy+. “This advanced system builds on a type III device, enhanced by the unique JAWAC sensor, to deliver unmatched accuracy in measuring respiratory effort and total sleep time. Additionally, Brizzy+ estimates micro-arousals and respiratory effort-related arousals (RERAs),” according to the statement.

“Nomics remains dedicated to revolutionizing sleep diagnostics through our augmented polygraph technology. We believe this approach offers the greatest potential to enhance NHS workflows by improving the quality of home sleep tests, reducing costs, and preserving the diagnostic depth provided by multi-signal systems. We look forward to collaborating with NICE, the NHS, and sleep specialists across all our markets to refine our solutions further and improve patient outcomes.”

ResMed NightOwl

NICE does not include ResMed’s NightOwl—which consists of a finger-worn wireless photoplethysmography sensor and accelerometer that measure peripheral arterial tone signal, oxygen saturation, body movement, and pulse rate—in its guidance because the device is awaiting a declaration of CE conformity due to a name change from the CE-marked NightOwl Mini, which uses a rechargeable battery, to NightOwl, which uses a non-rechargeable battery.

In an emailed statement, a ResMed spokesperson says, “Home sleep test devices including NightOwl have the potential to bring clinical and economic value to patients, providers, and healthcare systems around the world. ResMed is excited to continue pursuing globalization of NightOwl, maximizing its impact and bringing even more value to those we serve globally. NICE’s guidance affirms the importance of home sleep testing in improving care access, streamlining the pathway to diagnosis and care, and enhancing healthcare efficiency.”

Dive Deeper Into New Home Sleep Testing Technology