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Study record · validation · 2021

Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome

Edouard P, Campo D, Bartet P, Yang RY, and Bruyneel M

Journal of Clinical Sleep Medicine · 2021

Why this study matters to CircaTest

The canonical peer-reviewed validation of the Withings Sleep Analyzer for sleep apnea detection. Published in JCSM. The 88% sensitivity / 88.6% specificity figures (AHI ≥ 15) are the basis for the FDA 510(k) clearance Withings later received for the Sleep Rx variant. CircaTest cites this as the primary evidence for any Withings nearable apnea claim.

Abstract

STUDY OBJECTIVES: To assess the diagnostic performance of a nonintrusive device placed under the mattress to detect sleep apnea syndrome.…

Read the full abstract on the source →

Source: PUBMED · Excerpt for fair-use commentary; full abstract via the source link

Population

Sample size

n = 118

Age

adult; suspected obstructive sleep apnea

Reference standard

psg

118 patients with suspected OSA, single in-clinic night with simultaneous PSG and Withings Sleep Analyzer recording. Mean PSG-derived AHI was 31.2 events/h (SD 25.0).

Devices and metrics

Withings Sleep Analyzer

All studies for this device →
MetricValue95% CINote
Sensitivity88%Sensitivity for detecting AHI ≥ 15 events/h (moderate-severe sleep apnea).
Specificity88.6%Specificity for detecting AHI ≥ 15 events/h.
Accuracy92.6%AUROC = 0.926 at AHI ≥ 15 threshold (recorded as percent for display; the underlying metric is AUROC, not raw accuracy).
Sensitivity86%Sensitivity at the higher AHI ≥ 30 threshold (severe sleep apnea).
Specificity91.2%Specificity at AHI ≥ 30 threshold.

Cite this study

Edouard P, Campo D, Bartet P, Yang RY, and Bruyneel M (2021). Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome. Journal of Clinical Sleep Medicine. https://doi.org/10.5664/jcsm.9168

Source links

Added to the CircaTest meta-analysis on 2026-04-06. How CircaTest evaluates studies →