COVID-19 UpdateAs the situation surrounding COVID-19 (Coronavirus) continues to develop, Watermark Medical’s focus on the health and safety of our staff, partners, customers and patients is our top priority. We are closely monitoring guidance from the CDC and other public health organizations and taking appropriate action to ensure we continue to provide uninterrupted technical support, as well as maintain clinical and diagnostic services for our home sleep testing clients. While most of our technical and clinical staff are working remotely, we currently maintain shipping/receiving and quality assurance services from our office to manage device maintenance and repair requirements.
A few questions regarding the coronavirus outbreak have been specifically asked about the cleaning processes of the ARES device. Our cleaning procedure (when followed as described in the ARES Product Guide) has been validated and meets agency guidelines to mitigate the transfer risk of bacteria and viruses. For our customers safety, the ARES User Guide intended to be given or reviewed with each patient, includes instructions for the patient to place the device back in the plastic bag to return to the issuing facility. Once cleaned, storing the ARES device in a new resealable plastic bag will help ensure that the ARES remains clean and ready for the next patient use. Those who clean the devices after patient use can limit their chance of exposure by proper use of gloves and frequent washing of their hands. We are monitoring guidelines from CDC and other regulatory agencies and will adjust our procedure if their recommendations change.
Watermark Medical is unique in that we provide excellent Home Sleep Testing – the ARESTM system, which has been peer-reviewed and tested by several major medical publications.
The accuracy of ARESTM has been validated by several studies done under controlled laboratory settings, as well as unattended environments. The system has demonstrated a strong concordance with simultaneously collected PSG.
Our program is part of a comprehensive approach to sleep medicine. It is designed to be used in conjunction with our validated ARESTM Obstructive Sleep Apnea (OSA) questionnaire.
The ARESTM device is comfortable to wear, accessible, and user-friendly, making it easier than ever to gather critical information about patient sleep cycles. Our device is capable of accumulating up to three days of data. This provides comprehensive analytics to facilitate OSA diagnosis and measure the severity of the condition. From there, referred specialists within our network can provide patients with proper treatment.
For over a decade, pharmaceutical, medical device companies, and research clinicians have turned to us for research services, diagnostics, and therapeutic testing in the validation process, which precedes FDA approval. Watermark Medical prides itself in conducting clinical research and database science research to demonstrate the clinical elements of the ARESTM device. Our history of in-depth clinical studies and white papers supporting the effectiveness of our device include the following:
ARESTM questionnaire performs better than the Berlin questionnaire
The ARESTM questionnaire performed better than the Berlin questionnaire with higher sensitivity but lower specificity.
Validation study of a portable monitoring device for identifying OSA in a symptomatic patient population
One hundred forty-one patients wore ARESTM while undergoing a PSG study. Results of AHI from the ARESTM study were presented in the order of different scoring criteria – 4% oxygen desaturation alone, obstructive events with 1% desaturation plus surrogate arousal criteria. The sensitivity was 0.84 (95% confidence interval (CI): 0.77-0.90) and 0.97 (95% CI: 0.94-0.99), respectively. The specificity was 1, and 0.63 (95% CI: 0.55-0.71), respectively. The receiver operating curve had an area of 0.96 and 0.98, respectively. The ARESTM device has reasonable sensitivity and specificity for diagnosing severe OSAS in symptomatic Chinese patients.
The correlations between the ARESTM and PSG
The relationships between the ARES™and PSG for simultaneously acquired recordings was 0.96 using an apnea/hypopnea index with a 4% desaturation (AHI-4%), and 0.93 using a respiratory disturbance index based on Chicago criteria (RDI). The diagnostic sensitivity of in-lab ARES™ RDI was 0.95, and the specificity was 0.94; comparable measures to PSG for the in-home ARESTM RDI values were 0.85 and 0.91.
The vast majority of patients with a PSG SOREMP neverreceived MSLT testing
A new study advises considering a narcolepsy workupwhen a SOREMP is seen (especially if multiple) as well as a close follow-up ifPAP is chosen.
The ARESTM Home Sleep Test system provides sleep disorder patients with a proven method of conducting personalized sleep studies from the comfort of their homes. At Watermark Medical, our ARESTM system ensures higher completion rates and accuracy in diagnoses of obstructive sleep apnea. This program is backed by extensive research and clinical studies attesting to its effectiveness. If you’re ready to make the choice for better sleep, contact us today with any questions.