CAN ACTIGRAPHY OUTCOME MEASURES FROM EXISTING CLINICAL TRIALS PROVIDE A FRAMEWORK FOR SLEEP AND ACTIVITY ENDPOINT STANDARDS IN THE CLINICAL TRIAL OF THE FUTURE?

Author(s)

Mc Carthy M
ICON PLC, Dublin, Ireland

OBJECTIVES: The growing market for personal wellness technology has increased the awareness of the potential role of sleep and activity measures in clinical trials.   However there is significant debate around the clinical value of these endpoints, position of the devices and duration of the recording period.  90 Industry Sponsored Trials were identified from a comprehensive review of Clinical Trials.gov, EU Clinical Trials Register and The International Standard Randomised Controlled Trial Number register (ISRCTN) as having used Actigraphy (activity and sleep) derived outcome measures.  This retrospective analysis is designed to establish if there is commonality among the existing Actigraphy endpoints and study design that can provide a framework for future clinical trials.   METHODS: Systematic review of the subset of industry sponsored trials which had been filtered using the word “Actigraphy” and the brand names of the best known devices. These trials were then subdivided by therapeutic areas and analysed for outcome measures and study design. RESULTS: Therapeutic Areas (CNS, Dermatology, Respiratory, Cardiovascular, Diabetes, Oncology), Discrete and Common Endpoints: Sleep (47%), Activity (23%), PLM (12%). Wear time:  when stated varied from 10 hours to 4 weeks. CONCLUSIONS: The preponderance of the trials reviewed were in the CNS therapeutic area (73%). Actigraphy derived endpoints were used both as primary and secondary outcome measures.  Sleep endpoints were the most common outcome measures, however there was considerable variability regarding the sleep parameter selected,  the terminology used in the protocols and the wear time.   In order for the value of Actigraphy derived endpoints to be maximised and universally adopted, the choice of endpoint and study design need to be standardized.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PRM239

Topic

Study Approaches

Disease

Multiple Diseases

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