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Pharmaceutical

Pharmaceutical Drug Trials

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The Assessment of ‘Sleepiness’ in Human Drug Trials: A New Perspective
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Drug Trials
Neurology
Biomarkers
Alzheimer's
Epilepsy
Traumatic Brain Injury
Parkinson's
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Optalert’s revolutionary technology gives clinicians objective metrics for real time measurement of drowsiness and wakefulness.

Optalert was founded by Dr. Murray Johns, a sleep research pioneer and the inventor of the Epworth Sleepiness Scale (ESS), the internationally accepted scale of sleep propensity, widely used in sleep centres, research and clinical drug trials.

Optalert technology is the next generation in measuring drowsiness. It is an objective, quantitative, and reproducible test, which provides extensive data. Using infrared reflectance oculography, measurements of eye and eyelid movements are now able to be accurately quantified.

The efficacy and safety of drugs require assessments of their effects on drowsiness or wakefulness. There are numerous existing methods, however many are either subjective and are susceptible to biased results, or objective tests, which can be very time consuming. In many drug trials it is common practice to use both the Maintenance for Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS) in conjunction, in order to provide a more meaningful analysis.

For drug trials, we can now quantify drowsiness measurements, improve efficiencies of testing, reduce inclusion/exclusion criteria and compliance of subjects, and provide real quantitative data for analysis.

This data enables pharmaceutical companies to make faster, more informed decisions about the efficacy and safety of drug trials – whether that means taking drugs to market faster, or finding any deleterious effects, enabling companies to change direction and be more agile.

If you are working on a clinical drug trial and sleepiness, drowsiness, or wakefulness, is a primary or adverse effect, and would like to know more about how Optalert can help please contact us today. info@optalert.com

Research

The Optalert system is transforming the way medical professionals assess for drowsiness or wakefulness, and has potential for monitoring neurological conditions.

By combining technology and scientific algorithms, clinicians can now collect objective data to assist their understanding of the nature of impairment and the corresponding treatment needed to optimize recovery. Such studies are currently being investigated in the field of neurological disorders and potential biomarkers.

This ‘smart’ technology gives you the power to identify, track, and ultimately, could help to detect biomarkers and other precursors of neurological conditions, such as Parkinson’s, Epilepsy, Alzheimer’s, and Traumatic brain injury, to allow for early intervention.

Researchers have successfully measured the effects of sleep deprivation, stimulants such as caffeine and more recently are investigating connections into neurological conditions, such as possible biomarkers for prediction of Epileptic Seizures. Recent work by the company suggests that additional biomarkers for other neurological disorders could also be uncovered with Optalert’s technology and we are actively seeking collaboration partners.

If you are working in a neurological or other research field and would like to discuss how Optalert can help you, please contact us today at info@optalert.com


Epworth Sleepiness Scale (ESS)

Optalert Founding Director Dr Murray Johns first developed the ESS for adults in 1990 and then later for children and adolescents in 2015. He developed the scale to assess the ‘daytime sleepiness’ of patients in his own private practice of Sleep Medicine, the Epworth Sleep Centre, and consequently named it after that Centre which he had established in 1988.

The ESS is a self-administered questionnaire with eight questions. Respondents are asked to rate, on a four-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of eight item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person’s average sleep propensity in daily life (ASP), or their ‘daytime sleepiness’.


Optalert’s revolutionary technology in pharmaceutical trials

Changes in eye and eyelid movements, referred to as ‘ocular dynamics’, provide a direct link to fluctuations in human attention and alertness. Ocular movements, particularly eye blink parameters, are considered reliable physiological indicators of drowsiness levels. Blink characteristics during the eyelid closure and reopening show unique properties that can objectively quantify changes in drowsiness.


The amplitude-velocity ratios for blinks

In 2003, Founding Director of Optalert and world-renowned sleep researcher, Dr Murray Johns introduced amplitude-velocity ratios (AVRs) for blinks as a measure of the relative velocity of their movements.

His research found that in alert people, the amplitude (size) of upper eyelid movement during each blink is known to be very closely related to its peak velocity (speed). He also found the AVRs for the eyelid’s closing phase of a blink are different from those for the eyelid’s reopening phase of a blink, even though their amplitudes are usually the same.

The AVRs have been shown to increase with drowsiness, particularly for the eyelids reopening, i.e., the upper eyelid moves more slowly when re-opening after a blink in people when drowsy than when alert. These ratios avoid the need for calibration of either the amplitude or velocity in absolute terms. The ratios are also very stable between people, which mean they do not have to be adjusted for individuals.

Through his research, Dr Johns developed the patented Johns Drowsiness Scale (JDS) He also developed the Epworth Sleepiness Scale (ESS), which is now a world-standard method for measuring a subject’s general level of sleepiness in daily life. The JDS was developed specifically for use with Optalert’s technology, which uses a system of infrared (IR) reflectance oculography positioned in a sensor to monitor eye and eyelid movements, with particular emphasis on the velocity and duration of the upper eyelid during blinks. The system of IR oculography has enabled several ocular variables to be identified that can be used in combination to objectively quantify drowsiness with the ten-point scientifically-validated JDS.

Optalert’s patented JDS has now been packaged into a product specifically for the pharmaceutical industry which due to its ability to continuously and objectively monitor patients in real-time, is destined to positively change the nature and costs of pharmaceutical and clinical trials.

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