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.

Immediately after a lunch meeting, David Sullivan (CleveMed Software Quality Engineer) tweeted: Interesting presentation on sleep science during lunch by Dr. Robert Thomas. Ilya Gotfryd (Software Engineer), from a nearby cubicle, promptly echoed: Came back from an exciting sleep science presentation. Starting to view sleep as a window. The CleveMed Twitter page announced: “Fascinating lunch meeting presentation by Dr. Robert Thomas (BIDMC, a Harvard Medical School affiliate) on ‘Sleep as Window’”. Although the lunch-time talk was much-tweeted about by the CleveMed team, it was not the main focus of Dr. Thomas’ visit.

Dr. Robert Thomas of Beth Israel Deaconess Medical Center was in Cleveland this week to partner with CleveMed in developing and commercializing a new therapeutic technology for sleep apnea. Sleep apnea has many forms, like Obstructive (OSA), Central (CSA), and Complex (CompSA). OSA is the only form with an effective treatment - Continuous Positive Airway Pressure – CPAP. However, CSA and CompSA, which are strongly linked to serious heart and lung diseases remain largely untreated. It is suspected that more than 25% of Congestive Heart Failure (CHF) patients have CSA or CompSA. Furthermore, Central or Complex apnea events often coexist with OSA, which can compromise the effectiveness of the popular CPAP therapy.

The technology, which was created by Dr. Robert Thomas at BIDMC, Boston and Mr. Robert W. Daly of Wellesley, Massachusetts, is based on injecting small amounts of CO₂ levels into the patient while applying CPAP. A major contributor to CSA and CompSA is thought to be an increased sensitivity to CO₂ levels, which causes central apneas readily when the patients fall asleep. This is especially true during CPAP since the increase in breathing lowers CO₂ in those patients; thus, triggering central apnea. “By introducing 0.5% to 1% of CO₂ during CPAP, we have found that the patient′s normal breathing is restored“, said Dr. Thomas. “The key is to prevent a drop in CO₂; there is no need to increase CO₂ above wake levels. The implications are huge. Not only will such technology bring relief of symptoms to CSA and CompSA patients, but may also improve cardiac function itself, as the restoration of normal breathing may relieve stresses on the heart. The project with CleveMed will test the benefit on patients with and without CHF and both CSA and CompSA.”

Technology completion and clinical validation on more than 100 patients will be supported by a recent NIH SBIR Fast Track grant awarded to CleveMed with BIDMC and Wayne State University as the two clinical sites.

This post is an adaptation from CleveMed News Release: CleveMed to Collaborate with Robert Thomas MD on New Sleep Apnea Therapy

Kinesia is a system for objectively monitoring and tracking the severity of Parkinson’s disease symptoms in conjunction with clinician evaluations using the Unified Parkinson’s Disease Rating Scale (UPDRS). The device uses tiny motion sensors (accelerometers and gyroscopes) to collect patient symptom data and, using a Bluetooth radio, wirelessly transmits that information to a PC. An addition to the system has just been released which includes automated tremor scoring based on the 0-4 scoring method of the UPDRS. Before Kinesia, there was no objective way to consistently track symptoms, making this a large advance in the way Parkinson’s disease patients are monitored.

The Kinesia patient unit is worn on the hand and wrist while patients follow video instruction for completing upper extremity motor tasks. After the completion of the tasks, algorithms in the software automatically score three tremor tasks for evaluating rest, postural and kinetic tremor on a 0-4 scale based on the UPDRS. In addition to the scoring being automated and repeatable, the scores are provided with better resolution than the whole numbers given with the UPDRS. Kinesia will assign scores such as 1.29, 3.75 or 0.84 to provide clinicians with a more exact picture of a patient’s symptoms. Reports can be generated and tremor symptom history can be viewed by their clinician, assisting them in making decisions regarding the progression of the disease, the patient’s current medication or other methods of treatment. A peer reviewed publication documenting clinical utility was accepted by The Movement Disorders Journal and is currently available online at http://www3.interscience.wiley.com/journal/121634261/abstract

There are many other symptoms that affect PD patients outside of tremor, including bradykinesia (slowed movements or hesitations), rigidity, gait and balance issues and dyskinesias (wild, involuntary movements caused by an overabundance of dopamine in the brain – the result of a patient being overmedicated). Automated tremor scoring is only the beginning of the development of Kinesia . Researchers at CleveMed are in the process of conducting a large clinical trial involving three movement disorders centers and one hundred fifty PD patients. The data collected during this study will aid in the development of algorithms for automated scoring of bradykinesia and dyskinesias. The overall goal is to include scoring for a large majority of the motor symptoms that affect PD patients.