Isabella Hornick , 2025-05-18 18:27:00
Key takeaways:
- The Connected Wearables platform uses data from an FDA-cleared wearable proximal finger-mounted pulse oximeter.
- Patients have access to a mobile app, whereas clinicians have a dashboard with advanced algorithms.
SAN FRANCISCO — In two trials for sleep-related breathing diseases, a software platform analyzed nightly sleep metrics from a ring pulse oximeter, according to a presentation at the American Thoracic Society International Conference.
“[With this platform,] everyday clinicians will be able to focus more time on patient care and use data-generated insights to inform the care team on what really matters prior to a patient visit,” Ketan Mehta, MS, head of product and engineering for Connected Wearables at Apnimed, told Healio.
“This opens the door to trial simpler treatments/interventions in the future for more of the 80 million patients with OSA in the U.S. across pulmonary and sleep medicine and eventually primary care,” Mehta said.
In this analysis, Mehta and colleagues evaluated patients with sleep-related breathing diseases enrolled in either an ongoing open-label study of AD019 (Apnimed; n = 392) or an ongoing CPAP adherence feasibility study (n = 31), both of which used the Connected Wearables platform consisting of a mobile app for the patient, cloud services and a portal/dashboard with advanced algorithms for the clinician.
Notably, this platform — pending FDA clearance — is used in combination with an FDA-cleared wearable proximal finger-mounted pulse oximeter that records SpO2, pulse rate and motion overnight, according to the presentation.
In the open-label study, the endpoints and data collected using the ring pulse oximeter were considered exploratory.
Researchers reported that the SpO2 processor can measure various sleep metrics, including the mean and lowest SpO2, mean desaturation, oxygen desaturation index (ODI4), time below 90% (T90%), hypoxic burden and total recording time. Of these metrics, patients can access mean SpO2, ODI4, T90% and total recording time on the app.
“We automated the entire workflow to analyze the collected data, generate digital endpoints and summarize these endpoints across multiple nights of data using a simple clinician dashboard,” Mehta told Healio.
“This dashboard provides a simple and transparent overview of the patient journey,” he added. “This allows clinicians to confidently manage patient care with multiple interventions, including behavioral change(s).”
In addition to the above measures, researchers highlighted that the Connected Wearables platform also captures responses to patient-reported outcomes (PROs) via the mobile app, which are then uploaded to the cloud for analysis.
“PROs are collected on a specified schedule configured for each study, to push the instrument(s) to a subject’s mobile app used with the [Connected Wearables] platform,” researchers wrote on the presentation.
Eight electronic PROs were evaluated in the open-label study, including Epworth Sleepiness Scale, PROMIS-Fatigue and EQ-5D-5L, whereas only scaled motivation for treatment was collected in the CPAP adherence feasibility study using the mobile app, according to researchers.
Insights
Based on the number of nightly recordings in the open-label study, researchers observed “persisted engagement” throughout months of use. In this study, researchers also found that it is important to collect data over multiple nights “to capture a patient’s journey.”
“The exploratory digital endpoints we presented to clinicians with longitudinal remote data collection helped to assess baseline disease burden before treatment and then treatment response compared to this baseline,” Mehta told Healio.
When assessing data from the CPAP adherence feasibility study, researchers observed comparable user behavior across interventions.
Notably, researchers reported long engagement periods in both studies.
“The sustained patient interest in longitudinal remote data collection of their own physiological response to treatment for many weeks and months exceeded our expectations,” Mehta said. “Patients are excited to see their own simple ‘sleep study’ result after most nights.”
Performance metrics
Combining data from both the open-label study and the CPAP adherence feasibility study, researchers revealed that the Connected Wearables Platform has collected 130,217 hours of sleep data to date since July 2024 and 18,116 nightly recordings.
Additionally, 100 clinical sites are trained and onboarded on the platform, and 320 clinicians/staff are using the platform for clinical trials, according to the presentation.
“We remotely trained, onboarded and supported many clinical research sites across different studies using 30-minute web conferences so the site principal investigator and research staff could register, activate and monitor their patients using Apnimed’s Connected software platform to dispense our Wearable device to their patients,” Mehta told Healio.
“What surprised us is that sites have been able to use it so effectively and importantly, patients have been able to perform self-onboarding on their own,” he said.
Mehta also noted that use of the mobile app by age group was surprising.
“There is a general belief that users above 60 years of age face technical challenges or are not digitally savvy,” Mehta told Healio. “However, what we found was very different; our data show that users in the age group of 60 to 80-plus years are using the mobile app a lot more. Lower adherence to longitudinal remote data collection was observed more in subjects under the age of 40.”
Future research
Moving forward, Mehta said the insight they gained on night-to-night variability for their exploratory digital endpoints will inform the number of nights of data they collect before starting treatment in studies.
“We want to simplify remote data collection for routine patient care to one comfortable, easy-to-use wearable device cleared for medical use across multiple nights to assess disease burden and establish a reliable baseline before treatment,” Mehta told Healio. “Treatment could then be initiated and monitored with a similar number of nights per condition or dose.
“Think of treatment as a series of digitally enabled 2-week sprints,” he continued. “We call that digital medicine.”
Although patients have the option of a home test vs. in-lab polysomnography for diagnosing sleep apnea, Mehta said the at-home tests “are still cumbersome for routine patient care.”
“Most of the stakeholders involved with the patient care journey desire access to easy-to-understand metrics more frequently,” Mehta told Healio. “Any patient starting out with a remote data collection solution can be escalated at any point to more comprehensive multi-sensor sleep diagnostics for clinical decision support at any point on their patient journey.”
References:
For more information:
Ketan Mehta, MS, wishes to be contacted through Stephen Pittman at spittman@apnimed.com.
