Highlights
- CHDR has extensive experience studying sleep-aid medications, including the first orexin antagonists.
- We can provide sponsors with detailed information regarding the optimal dose for treating specific sleep disorders.
- In-house driving simulators enable us to test whether a sleep medication affects driving performance.
- Polysomnography (PSG) can be used to examine a compound’s precise effects on a wide range of neurotransmitter systems.
- We have developed advanced tools to quantify a compound’s effects on the sleep cycle and model its pharmacokinetic and pharmacodynamic (PK/PD) profile.
- Combining polysomnography with NeuroCart® can provide a comprehensive neuropharmacological profile of a test compound.
Summary
We have significant experience in studying the effects of CNS drugs on sleep, including medications for patients with sleeping disorders such as narcolepsy and insomnia. However, commonly used medications for psychiatric and neurological conditions, such as depression and Alzheimer’s disease, can also influence sleep. Therefore, studying sleeping subjects in a clinical trial can increase our knowledge regarding a compound’s neuropharmacology. After all, although sleep may appear to be a passive process, it requires the coordinated activity of many neurotransmitter systems in the CNS.
Methodologies
- Polysomnography (PSG)
- Standardised sleep stage ratings in conjunction with the Siesta group
- Multiple sleep latency test (MSLT) and quantitative EEG analyses
- Situational traffic noise sleep disturbance model
- Actigraphic and kinegraphic monitoring
- Subjective sleep questionnaires
- Circadian rhythm analyses
- Endocrine, pharmacokinetic, metabolic and autonomic measures
- Round-the-clock NeuroCart® CNS measurements, including:
- night-time, daytime and residual functional (‘hangover’) wake assessments
- alertness and vigilance, cognition and memory, performance, creativity, mood and other subjective states
Practical answers to important research questions
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How does our compound compare with other sleep medications?
Using NeuroCart®, polysomnography, and driving simulators, CHDR can generate a comprehensive profile of a new sleep aid’s intended and/or unintended effects. Even in the earliest stages of clinical drug development, relevant information can be collected using healthy volunteers, and these results can be compared with results obtained using established sleep aids (such as zolpidem).
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Does our CNS drug affect driving performance?
Taking a sleep aid or other CNS drug can impede driving performance. To study these effects in detail, CHDR uses a validated driving simulator with both healthy subjects and patients. The driving simulator can also be used to compare the effects of a new compound with the effects of established sleep aids, alcohol, and other compounds. To quantify the intensity and duration of the drug’s effects on driving performance, the simulator can be used repeatedly over the course of several hours.
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Which neurotransmitter systems are affected by our compound, and how does this affect sleep?
Polysomnography is currently being developed as a sophisticated biomarker that can be used to measure pharmacological CNS effects. Studies using healthy volunteers and patients can provide detailed information regarding the test compound’s effects on both the quality and quantity of sleep, as well as providing important insight into the compound’s effects on various neurotransmitter systems.
