CleveMed Blogs

About Sleep Apnea:

According to the National Institutes of Health, 50 to 70 million Americans are affected by chronic sleep disorders which can significantly diminish health, alertness and safety. An estimated 18 million Americans have sleep apnea, one of the most common sleep disorders. Yet, many sufferers are undiagnosed. Untreated sleep disorders can lead to hypertension, heart disease, stroke, depression, diabetes and other chronic disorders. In order for sleep apnea to be diagnosed, a patient normally undergoes a polysomnography (PSG), which is a noninvasive, pain-free procedure that usually requires spending a night in a sleep lab. During a PSG study, a sleep technologist records multiple biological functions during sleep, such as brain wave activity, eye movement, muscle tone, heart rhythm and breathing using electrodes and monitors placed on the head, chest and legs.

About DreamPort:

CleveMed recently introduced DreamPort™, an accessory to CleveMed’s Sapphire PSG™ (full PSG wireless system). Using broadband technology and built-in camera, DreamPort is a gateway to transmit full PSG data from the patient’s location to a sleep lab, thus, allowing remote attendance for patients who may be anxious or incapable of attending a sleep lab. With this new emerging medical device technology, diagnosing and treating sleep disorders has become timelier.

Why DreamPort is Suitable for Clinical Trials:

DreamPort is suitable for clinical trials as it allows for cost effective research studies to be conducted nearly anywhere. According to Cutting Edge Information, the average drug company spends about 37% of their overall R&D budgets on clinical trials. The average per-patient cost of clinical trials ranges roughly from $5,500 $7,600¹. Typical clinical trials follow a set of rules called a protocol and are managed by doctors. The studies are commonly run by nurses or other health care professionals². Now, DreamPort gives clinicians and researchers greater flexibility to conduct clinical trials where the patient is. Researchers and clinicians are able to obtain new types of research, like location specific research -home, hotel, hospital or lab; which can lead to support and establish a wider patient base.

The cost of home testing is a fraction of the cost of in-lab testing and can be less than the cost of using personnel for a full night sleep study. The average in-lab sleep studies cost range between $1,000-$5,000 a night. The cost of home studies range 35% to 88% lower than in-lab studies. The lower cost of home sleep studies makes DreamPort a practicable screening tool to collect meaningful research for patients with suspected sleep disorders, like Obstructive Sleep Apnea (OSA).³

This post draws on the experience of CleveMed professionals and professionals in the Sleep Disorder industry.

CleveMed is a medical device company that specializes in developing and manufacturing miniaturized wireless monitoring devices for the clinical, research and educational fields. Every device that is developed, whether it’s for sleep disorder monitoring, movement disorder monitoring, physiological research or biomedical engineering education, is wireless and handheld or patient worn. So, why the emphasis on wireless technology?

Wireless devices are emerging as a stronghold in the medical device and research fields because of the many advantages the technology offers. Wireless equipment gives the patient or subject being monitored the ability to move freely and naturally. Using a wireless device while monitoring a patient for a sleep disorder provides the ability to get up during the study and move around without the need to be disconnected. Wireless physiological monitoring equipment increases the environments in which a subject can be monitored, such as running on a treadmill or riding a bike.

In addition to increased applications, wireless equipment increases patient and subject safety. The need to be connected to a computer or large cart mounted system is eliminated when using a wireless device. Large obtrusive wires are not necessary and not a concern to the user, letting them move naturally without the worry of pulling on wires that are connected to computers or large cart mounted systems. Wireless also means that the user does not need to be connected to any power outlets, as all CleveMed devices are powered by batteries.

Many organizations are taking advantage of the increased flexibility and reduced costs that wireless devices offer. Using wireless systems can help turn any room into a sleep lab, motion analysis center or physiological monitoring research room because there is no need for complicated wiring or extensive setup.

CleveMed will be attending and exhibiting at the Gait and Clinical Movement Analysis Society’s (GCMAS) 14th Annual Meeting in Denver, Colorado. The meeting will be taking place March 9-14.

GCMAS is a society that is made up of orthopedic surgeons, neurologists, developmental pediatricians, physiatrists, physical and occupational therapists, kinesiologists, engineers and many others who are interested in human movement. The professional members of GCMAS are all interested in the advancement of scientific knowledge of gait and human movement analysis in both research and clinical settings.

CleveMed will be showcasing KinetiSense, a compact, lightweight, wireless system for measuring motion and electrical muscle activity (EMG). KinetiSense utilizes a small subject worn device that measures three degrees of linear acceleration and three degrees of angular velocity with accelerometers and gyroscopes. The device also has the option of two channels of EMG for a total of eight channels of data. KinetiSense can communicate in real time with a PC via a Bluetooth^™ radio link or data can be stored in memory. The small size and wireless aspect of the device make the system suitable for a number of research applications, including gait measurement, biomechanics, rehabilitation and any other situation in which movement monitoring and analysis is desired.

A second product on display will be BioCapture, a wireless data acquisition and research system. BioCapture uses the BioRadio 150, a wireless 12 channel programmable physiological monitor. The user can measure up to 8 channels of electrical muscle activity (EMG) on the available programmable inputs. Data is then sent in real time to a PC and displayed and stored using the BioCapture software interface. LabVIEW^™ and MATLAB^® drivers allow the user to write customized interfaces around the BioRadio 150 hardware for real-time acquisition or post processing. Data is also saved in standard ASCII file format for easy import into third party packages, making the system appropriate for a number of custom research applications.