Sleep Disorders

Cognitive impairment is a core aspect of sleep and wakefulness disorders. With evolving therapeutics aimed directly at addressing these deficits, the importance of robust cognitive assessment and data quality strategies in clinical trials continues to grow.

With hands-on expertise supporting cognitive assessment in pivotal sleep disorder studies, Cogstate provides guidance and support to help your team gather quality data via validated digital tests of sustained attention and cognition, as well as standard outcome measurement collection.

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Sleep and Cognition are Fundamentally Linked

A growing body of evidence underscores that sleep health and cognition are tightly interconnected. Longitudinal studies show that sleep disruption and short sleep duration can predict cognitive decline over time. In clinical trials, this relationship is actionable: sleep disorders can disrupt brain function in ways that are measurable with sensitive cognitive endpoints—and, importantly, those impairments may improve with effective treatment.

The Cogstate team of cognitive scientists and statisticians have the expertise to advise your team on vital study considerations, help you answer key drug development questions, and reduce risk and uncertainty in your trial. With access to thousands of cognitive data profiles—and from decades supporting drug development work—Cogstate can advise your team on endpoint selection, powering decisions, and interpretation of study results supportive of product efficacy, safety, and differentiating claims.

Improve Outcome Measurement Collection

Cogstate digital cognitive assessments help teams capture both disease-related impairment and treatment-related improvement, using a validated, scalable platform that supports consistent measurement across sites and over time.

Cogstate provides rater and test administrator training for accurate data collection in sleep related trials. We support the deployment of Patient Reported Outcomes including ESS, PSQI, ISI, FSS, and KSS. We also provide training for rater monitored assessments such MWT and MSLT and can support the use of actigraphy devices to assess sleep-wake patterns.

Leverage Sensitive and Reliable Digital Tests

Cogstate digital tests provide valid and reliable measurement of distinct domains of cognition and enable you to capture a complete and nuanced picture of a participant’s cognitive state.

Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials.

In recent sleep disorder clinical trials, sponsors have utilized a core battery of Cogstate tests including PVT (vigilance), CPAL (learning/memory), ONB (working memory), and iDSST (psychomotor speed/executive function). Other studies have utilized DET and IDN (reaction time/attention), OCL and ISLT (learning and memory), and paradigms such as SART and GMLT. Cogstate can help you determine the unique combination to help your study measure objective cognitive performance and meaningful changes.

More on Digital Assessments

Sample Sleep Disorder Battery

The tests included are a sample battery. Final battery recommendations vary based on study needs.

Cogstate Tests:• Psychomotor Vigilance (Sustained or Vigilant Attention)
• Sustained Attention to Response (Sustained Attention)
• Continuous Paired Associate Learning (Paired Associate Learning)
• International Digit Symbol Substitution - Symbols (Processing Speed)
• One Back (Working Memory)
Length:Approx 27 minutes
(depending on the number of tests included in the battery)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

Case Example of Cogstate Sleep Disorder Solutions in Action

Development of New Digital Cognitive Test Supports Cognitive Measurement in Sleep-Related Program of Trials

A clinical study team at a large pharmaceutical company were developing a new wake-promoting compound and was interested in its potential impacts on cognition. They enlisted Cogstate to develop and implement a version of a gold-standard sleep measurement tool known as the Psychomotor Vigilance Test (PVT) within the Cogstate assessment system for use in their program. The high technical and timing precision of the Cogstate assessment system allowed the company to apply the PVT in their early development and late phase clinical trial programs. This also allowed them to leverage Cogstate distribution, training, quality assurance, and analyses systems. The Phase 2 study results were sufficient for the study team to continue to utilize the Cogstate PVT as key secondary outcome in their ongoing Phase 3 program of studies.

How can we help you optimize the measurement of brain health?

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