Evaluation of a Novel Device to Assess Obstructive Sleep Apnea and Body Position
Janna Rae Raphelson, M.D., C.M.; Imran M. Ahmed, M.D.; Sonia Ancoli-Israel, Ph.D.; Joseph Ojile, M.D.; Suzanne Pearson, RPSGT, RST; Nathan Bennett, MEng; Matthew Lee Uhles, RPSGT, RST; Chelsie Rohrscheib, Ph.D.; Atul Malhotra, M.D.
Published in the Journal of Clinical Sleep Medicine.
Study Objectives: Obstructive sleep apnea is a prevalent disease with well-known complications when left untreated. Advances in sleep-disordered breathing diagnosis may increase detection and appropriate treatment. The Wesper device is a recently developed portable system with specialized wearable patches that can measure respiratory effort, derived airflow, estimated air pressure, and body position. This study sought to compare the diagnostic ability of the novel Wesper device with the gold standard of polysomnography.
Methods: Patients enrolled in the study underwent simultaneous polysomnography and Wesper device testing in a sleep laboratory setting. Data were collected and scored by readers blinded to all patient information, and the primary reader was blinded to the testing method. The accuracy of the Wesper device was determined by calculation of the Pearson correlation and Bland-Altman limits of agreement of apnea-hypopnea indices between testing methods. Adverse events were also recorded.
Results: A total of 53 patients were enrolled in the study and 45 patients were included in the final analysis. Pearson correlation between polysomnography and Wesper device apnea-hypopnea index determinations was 0.951, which met the primary endpoint goal (P = .0003; Figure 1). The Bland-Altman 95% limits of agreement were -8.05 and 6.38, which showed strong agreement and met the endpoint goal (P < .001; Figure 2). There were no adverse events or serious adverse events noted. For OSA severity classification, Wesper demonstrated high diagnostic performance, with sensitivity/specificity of 0.80/0.97 for AHI < 5 events/h, 0.88/0.75 for mild OSA (AHI 5 to 15 events/h), and 0.73/0.93 for AHI ≥ 15 events/h.
Figure 1. Correlation: Wesper AHI vs. PSG
Figure 2. Bland-Altman: Wesper AHI vs. PSG
Conclusions: The Wesper device compares favorably with gold-standard polysomnography. Given the lack of safety concerns, we advocate for further study regarding its utility in diagnosis and management of sleep apnea in the future.
Wesper develops FDA-cleared home sleep testing medical devices used by clinicians. A medical provider orders the test, and Wesper provides full access to raw data for clinician review. Providers can learn more on the Wesper professional page.
This article is for general information and is not medical advice. Talk to a healthcare provider about your sleep health.
