Background The respiratory rate (RR) is a critical vital sign controlled by not only metabolic factors but behavior while awake. The prevalence of obstructive sleep apnea (OSA) is remarkably high. Therefore, a non-constraining and non-contact respiratory monitor to measure the RR both while awake and asleep is preferable.
Methods A millimeter wave radar (MWR) device was used for RR monitoring of participants suspected of OSA while awake (supine before and after polysomnography [PSG], sitting, and positioned on both sides) and asleep. Apnea and hypopnea during 1 hour of sleep (AHI) by PSG was compared with 1 hour of respiratory events (REI) judged by MWR. Portable monitoring (PM) and percutaneous arterial O2 (SpO2) monitoring were done simultaneously.
Results Correlations between the RR by MWR and respiratory inductance plethysmography at PSG while awake in every measured position including the supine position before and after PSG were very high (r=0.92∼0.99) (n=60). The REI by MWR were significantly correlated with AHI determined by PSG, PM, or SpO2 monitoring (p<0.001). Brand-Altman plot showed that the MWR for AHI monitoring was acceptable. Predicted AHI by MWR relative to PSG was almost the same as with PM or SpO2 monitoring.
Conclusions The developed MWR respiratory monitor was useful during wakefulness and sleep, including detection of apnea and hypopnea. This system can be useful in multiple medical settings such as critical care with and without sleep apnea, pandemic infection, elder care at home, etc. Trial registration number: UMIN000045833 (http://www.umin/ac.jp)
Competing Interest StatementKazuo Chin reports funding from Eizai, Aculys Pharma, Magnet, and The Japan Research Foundation for Healthy Aging. He has received consulting fees from Shionogi, Aculys Pharma, and Eli Lilly. Additionally, he reports financial interests related to Philips Japan, Fukuda Denshi, Fukuda Lifetec Tokyo, and ResMed, which have provided funds for the Department of Sleep Medicine and Respiratory Care at his institution. Shigeaki Okumura reports payment for an oral presentation from Philips Japan at the 22nd CPAP Research meeting. He also holds stock options from MaRI Co., Ltd. through his institution. Kimihiko Murase reports that the department of Advanced Medicine for Respiratory Failure of Kyoto University Graduate School of Medicine is funded by grants from Teijin Pharma to Kyoto University. Hironobu Sunadome reports funding from Philips Japan, Fukuda Denshi, Fukuda Lifetec Keiji, and ResMed. Susumu Sato reports funding from Nippon Boehringer Ingelheim. Additionally, Philips Japan, Fukuda Denshi, Fukuda Lifetec Keiji, and ResMed have provided funds to his institution. Toyohiro Hirai reports funding from Philips Japan, Fukuda Denshi, Fukuda Lifetec Keiji, and ResMed. Yasuhiro Gon reports that Philips Japan, Fukuda Denshi, Fukuda Lifetec Tokyo, and ResMed Japan have made donations to an endowed department at Nihon University. Takuya Sakamoto reports royalties from Ohmsha Ltd. and MaRI Co., Ltd. He has received consulting fees from GLORY LTD., Sumitomo Electric Industries Ltd., and Mitsubishi Electric Corporation, with payments made to his institution. He has also received honoraria for lectures and presentations from several organizations, including Science & Technology Co., Ltd., Think&Act, Inc., KEYCOM Corporation, SINSHU UNIVERSITY, The Institute of Electronics, Information and Communication Engineers (IEICE), Sony Semiconductor Solutions Corporation, SENSAIT Council (SAIC), Kyoto University Original Co., Ltd., Japan Human Factors and Ergonomics Society, Kyoto Research Park, Advanced Science, Technology & Management Research Institute of KYOTO, and the Science and Technology in Society (STS) Forum Kyoto Executive Committee. He reports planned, issued, or pending patents with US Provisional Patent Application numbers 63275949 and 63299958. Hirofumi Taki reports honoraria for lectures from Kyoto University, Advanced Science, Technology & Management Research Institute of KYOTO, Ritsumeikan University, Kyoto Research Park Corp., and the Public Foundation of Kansai Research Institute. He also holds stocks and stock options from MaRI Co., Ltd. through his institution. No other authors have conflicts of interest to report.
Clinical TrialUMIN000045833
Funding StatementThis paper is partly based on results obtained from a project, JPNP23019, subsidized by the New Energy and Industrial Technology Development Organization (NEDO), KYOTO Industrial Support Organization 21, a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology in Japan (23K07638, 19H02155, 21H03427, 23H01420, S23048, 23K21659, 23K26115), Japan Science and Technology Agency (JPMJMI22J2, JPMJCE1307, JPMJPR1873), Japan Science and Technology Agency, the Center of Innovation Program, and the Global University Project from Japan Science and Technology Agency, Japan Agency for Medical Research and Development (AMED) under Grant Numbers wm042501, the SECOM Science and Technology Foundation, the Intractable Respiratory Diseases and Pulmonary Hypertension Research Group from the Ministry of Health, Labor and Welfare of Japan (20FC1027 and 23FC1031), MaRI Co., Ltd, and Quanta Computer Inc.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee/IRB of the Nihon University Itabashi Hospital Clinical Research Review Board (RK-210914-5) gave ethical approval for this work.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors.
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