Validity of a commercial wearable sleep tracker in adult insomnia disorder patients and good sleepers

Abstract Objectives To compare the accuracy of the commercial Fitbit Flex device (FF) with polysomnography (PSG; the gold-standard method) in insomnia disorder patients and good sleepers. Methods Participants wore an FF and actigraph while undergoing overnight PSG. Primary outcomes were intraclass correlation coefficients (ICCs) of the total sleep time (TST) and sleep efficiency (SE), and the frequency of clinically acceptable agreement between the FF in normal mode (FFN) and PSG. The sensitivity, specificity, and accuracy of detecting sleep epochs were compared among FFN, actigraphy, and PSG. Results The ICCs of the TST between FFN and PSG in the insomnia (ICC = 0.886) and good-sleepers (ICC = 0.974) groups were excellent, but the ICC of SE was only fair in both groups. The TST and SE were overestimated for FFN by 6.5 min and 1.75%, respectively, in good sleepers, and by 32.9 min and 7.9% in the insomnia group with respect to PSG. The frequency of acceptable agreement of FFN and PSG was significantly lower ( p = 0.006) for the insomnia group (39.4%) than for the good-sleepers group (82.4%). The sensitivity and accuracy of FFN in an epoch-by-epoch comparison with PSG was good and comparable to those of actigraphy, but the specificity was poor in both groups. Conclusions The ICC of TST in the FFN–PSG comparison was excellent in both groups, and the frequency of agreement was high in good sleepers but significantly lower in insomnia patients. These limitations need to be considered when applying commercial sleep trackers for clinical and research purposes in insomnia.