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Guidelines for the development, performance evaluation and validation of new sleep technologies (DEVSleepTech

Gabriel Natan Pires1,2,3, Erna S Arnardóttir4,5, Sébastien Bailly6

  • 1Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.

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Summary

New sleep technologies require rigorous validation. This study outlines a Delphi consensus protocol to establish standardized guidelines for developing, evaluating, and validating novel sleep devices and technologies.

Keywords:
Delphiconsensusdigital healthdigital medicineguidelinesmobile applicationssleep technologysleep trackerssmartphonessmartwatcheswearables

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Area of Science:

  • Biomedical Engineering
  • Sleep Science
  • Technology Development

Background:

  • Rapid advancement of sleep technologies raises concerns regarding their validation and accuracy.
  • Many consumer sleep technologies lack rigorous testing against gold standards or regulatory approval.
  • Existing recommendations for sleep technology evaluation often lack standardized methodology and comprehensive scope.

Purpose of the Study:

  • To establish standardized guidelines for the development, performance evaluation, and validation of new sleep devices and technologies.
  • To address the need for a systematic approach to ensure the reliability and accuracy of emerging sleep solutions.
  • To provide a framework for researchers, companies, and regulatory agencies involved in sleep technology innovation.

Main Methods:

  • A Delphi consensus study protocol is described.
  • The study aims to gather expert opinions to formulate comprehensive guidelines.
  • Focus on creating a standardized methodology for evaluating new sleep technologies.

Main Results:

  • Development of a consensus-based protocol for sleep technology validation.
  • Establishment of guidelines for performance evaluation and development processes.
  • Recommendations are intended to assess overall procedures, not individual studies.

Conclusions:

  • The developed guidelines will aid researchers in appraising the reliability of new sleep technologies.
  • Companies can utilize these guidelines for developing and refining their sleep products.
  • Regulatory agencies can employ these guidelines for evaluating technologies seeking approval or integration into health systems.