Sleep Methodology in CNS Trials Working Group
Chairs: Margaret Moline, PhD; Georg Dorffner, PhD
Upcoming Activity: Working Group Meeting, 21st Annual Scientific Meeting, 19-21 February 2025, Washington DC
This working group started in February 2024 with the goal of contributing to a better understanding of the use of sleep-related measurement methodology in CNS trials, as well as promoting their use. Since then the WG has made progress toward two deliverables:
- A review paper on sleep and vigilance-related endpoints that have been proven to be potential biomarkers for predicting or monitoring different psychiatric and neurological disorders
- A consensus paper on validation methods for novel instruments (such as portable EEG devices, photo-plethysmography, actigraphy, etc.) deriving such trial endpoints.
This session will be mainly devoted to discussing the materials that have been collected toward the first deliverable and to preparing the next steps for the second one.
Most Recent Activity: Working Group Meeting, 2024 Autumn Conference, 12-13 September 2024, San Diego, CA – View summary – view slides
INAUGURAL MEETING: 20th Annual Scientific Meeting, view summary, 21-23 February 2024, Washington DC – view slides
Sleep is a naturally occurring state of mind and body accompanied by recurrent state of reduced responsiveness to external stimulation that is accompanied by complex and predictable changes in physiology The main idea behind this working group is the fact that both nocturnal sleep and its diurnal counterparts (vigilance, wakefulness, fatigue, somnolence, etc.) are such central physiological states that they are affected by most neurological and psychiatric disorders and thus deserve attention in a large number of CNS trials. Current methodologies of objectively measuring sleep and wakefulness, such as polysomnography or multiple sleep latency tests (considered “gold standard” in many respects), all have advantages as well as major disadvantages preventing them from being more widely used in trials. In this context, possible foci of the working group are:
• A critical assessment of various modalities for characterizing sleep, wakefulness and related states and for assessing the impact of clinical trial interventions on these states. The analysis of alternative methods of measuring sleep and wakefulness and their potential applicability in CNS trials.
• Criteria for proper validation of such methods against the gold standard
• The relationship of such objective methods of measurement with subjective assessments of sleep and wakefulness and the exploitation thereof
• Key issues in the development of novel modalities of assessing sleep, wakefulness and related states that would contribute to our understanding of the impact of such interventions while being acceptable to regulatory and competent authorities.
Consequently, possible products as the outcome of the working group are:
• Systematic reviews on the evidence of the reliability and validity of different instruments for measuring sleep and wakefulness
• A consensus paper on criteria and validation strategies for measurement instruments
• The initiation of a pre-competitive study with industry participation aimed at benchmarking certain instruments for their use in CNS trials