Consumer Sleep Technologies: How to Balance the Promises of New Technology with Evidence-Based Medicine and Clinical Guidelines

Abstract

Response to Watson et al. Will consumer sleep technologies change the way we practice sleep medicine?

Alternative algorithms and devices in sleep apnoea diagnosis: what we know and what we expect

“…Devices come from consumer devices designed to quantify yourself and aiming for improving performance and physical fitness and now they evolve to medical devices providing some kind of diagnosis with until now, uncertified accuracy. This means that validation studies are needed, that data transmission and data storage needs to be secure and data access must be regulated [ 33 , 34 ]. The European funded ASCLEPIOS project is developing secure access for a medical cloud for sleep medicine data ( https://www.asclepios-project.eu/ accessed 16 July 2020).…”

The Importance of Evidence-Based Medicine and Clinical Guidelines: Meaningful and Clinically Actionable Information Cannot be Compromised for the Convenience of Consumer Sleep Data

“…The US Food and Drug Administration (FDA) addresses this finding, as the AASM Technology Presidential Committee points out in response to Watson and colleagues, through a pathway for "Software as a Medical Device" (SaMD). 2,8,9 SaMD is not an easy path, nor should it be given what is at stake: peoples' quality of life and health. The guide for SaMD is based on consensus among the International Medical Device Regulator's Forum (http://www.imdrf.org) that has defined the patient/practitioner interaction to use data from SaMD to either "inform" or "drive" clinical management.…”

“…In their letter to the editor of Journal of Clinical Sleep Medicine, Watson et al 1 raise important questions worth dissecting in light of the response from the American Academy of Sleep Medicine (AASM) Technology Presidential Committee. 2 Not many market segments can claim an addressable market to be "everyone." This has not escaped various savvy businesses that have sprung up over the past decade to bring innovative consumer solutions with unsubstantiated claims from measuring sleep quantity and sleep quality offered to improve health outcomes.…”

Public Awareness, Medical Integration, and Innovation in Sleep Medicine

“…

On behalf of the Board of Directors and the Technology Presidential Committee of the American Academy of Sleep Medicine (AASM), we appreciate the feedback from Solveig Magnusdottir, MD, MBA, in response to the AASM position statement on consumer sleep technology and our previous letter to the editor. [1][2][3] We agree that although consumer sleep technology has the potential to improve our ability to increase awareness of and track sleep disorders through multi-night testing in the home environment, scientific validation is necessary for consumer sleep technology to have a significant role in clinical practice.We also agree with Dr. Magnusdottir's statement that, "AASM has a leadership obligation to facilitate increased public awareness of sleep disorders and to support improved integration of sleep health into medical care in a responsible manner. To establish common ground, AASM needs to embrace innovation in sleep medicine."

…”

“…On behalf of the Board of Directors and the Technology Presidential Committee of the American Academy of Sleep Medicine (AASM), we appreciate the feedback from Solveig Magnusdottir, MD, MBA, in response to the AASM position statement on consumer sleep technology and our previous letter to the editor. [1][2][3] We agree that although consumer sleep technology has the potential to improve our ability to increase awareness of and track sleep disorders through multi-night testing in the home environment, scientific validation is necessary for consumer sleep technology to have a significant role in clinical practice.…”