Guidelines for the development, performance evaluation and validation of new sleep technologies (DEVSleepTech guidelines) - a protocol for a Delphi consensus study.

New sleep technologies are being developed, refined and delivered at a fast pace. However, there are serious concerns about the validation and accuracy of new sleep-related technologies being made available, as many of them, especially consumer-sleep technologies, have not been tested in comparison with gold-standard methods or have been approved by health regulatory agencies. The importance of proper validation and performance evaluation of new sleep technologies has already been discussed in previous studies and some recommendations have already been published, but most of them do not employ standardized methodology and are not able to cover all aspects of new sleep technologies. The current protocol describes the methods of a Delphi consensus study to create guidelines for the development, performance evaluation and validation of new sleep devices and technologies. The resulting recommendations are not intended to be used as a quality assessment tool to evaluate individual articles, but rather to evaluate the overall procedures, studies and experiments performed to develop, evaluate performance and validate new technologies. We hope these guidelines can be helpful for researchers who work with new sleep technologies on the appraisal of their reliability and validation, for companies who are working on the development and refinement of new sleep technologies, and by regulatory agencies to evaluate new technologies that are looking for registration, approval or inclusion on health systems.