June 15, 2024

Vitavo Yage

Best Health Creates a Happy Life

FDA-cleared home sleep apnea testing devices

8 min read

We reviewed devices that have already received FDA clearance and analyzed the conditions that applied to HSATs that are currently in development for FDA clearance. We identified characteristic changes in the evolution of HSATs and provided recommendations for their development and clearance. The actual development requirements were categorized into safety and clinical effectiveness, which constitute crucial aspects of medical device evaluation. Regarding safety, adherence to international standards was identified as a key consideration. Regarding clinical effectiveness, the importance of clinical trial results, particularly those related to primary measures derived through manufacturer-specific algorithms, was emphasized. Notably, no regulatory enforcement or clear criteria for recognizing clinical trial performance were identified.

Several characteristic trends derived from FDA-cleared HSAT reports can be interpreted to originate in the following context: The number of FDA clearances for HSAT devices saw a significant spike in 2022, likely attributed to the heightened prevalence of home sleep testing referrals amid the COVID-19 pandemic, which prompted a reduction in hospital visits and an increase in social distancing23. However, concluding whether this marks a sustained upward trend remains premature. Continuous monitoring of the number of clearances in the coming years remains necessary to discern any enduring patterns. A notable trend is the rise in Type-3 sleep monitoring devices and a decline in Type-4 devices among FDA-cleared products. Previous reviews indicate a lack of evidence supporting the independent use of Type-4 devices, and the AASM recommends Type-3 devices for routine sleep testing24. Type-4 devices may simplify testing; however, their clinical validity has not been fully established. Regarding device types and usage, wearable devices continued to dominate; however, a gradual increase in the adoption of patch-type monitoring devices was observed, indicating a growing emphasis on ease of use and user experience. Furthermore, the intended use has expanded beyond home settings to encompass a full range, including healthcare/clinical applications. This transition could be facilitated by advancements in sensor and analytics technology, enhancing the necessary performance attributes of HSATs, including sensor miniaturization and increased sensitivity. Respiratory analysis emerged as the primary application of HSATs, with sleep analysis included in > 45% of FDA-cleared products. Notably, no products exclusively dedicated to sleep analysis received clearance after 2011, and those with sleep analysis tended to be combined with respiratory analysis or a pulse oximeter. This contrasts with the consistent FDA clearance of products exclusively designed for respiratory analysis, a trend likely driven by the substantial demand for respiratory analysis in diagnosing conditions like obstructive sleep apnea (OSA). The more complex measurement system required for sleep analysis, involving elements such as EEG, distinguishes it from the relatively straightforward nature of respiratory analysis.

Eleven out of 21 reports submitted to the FDA for clearance between 2003 and 2013 included standards, and the number increased to 33 out of 37 between 2014 and 2023; this can be attributed to heightened manufacturer awareness of safety and the influence of diversifying use situations and expanding functions that necessitate compliance with standards. The standards covered varied according to the type of sleep monitoring device. Type-2 and Type-3 devices are more likely to specify electrical characteristics, such as electrical safety and EMC. Interestingly, Type-2 reports are more likely to list standards for risk management and performance evaluation, whereas Type-3 reports include standards for cybersecurity and degree of protection packages that are not found in other types of reports. In contrast, Type-4 devices have a significantly higher percentage associated with the category “not specified.” Several possible reasons can explain the high number of “not specified” instances in Type-4 devices. First, four out of eight reports had been submitted a long time ago (before 2010) and do not include specifications. Additionally, the subsequent two reports focused on software, such as smartphone apps, which do not apply to the standard.

The frequency of standards listed in the report has exhibited variations over the years. Notably, usability, software validation, battery safety, and quality management are increasingly prevalent in clearance submissions among the specification categories. The rise in the frequency of usability-related specifications can be interpreted as a response to the growing significance of interface design, aimed at minimizing usage errors and enhancing patient and user safety. This trend is further underscored by the expansion of device operators from specialized technicians to the general public. Furthermore, the increased occurrence of software validation specifications likely reflects the expanding use of information technology in healthcare, emphasizing the need for robust development frameworks to ensure the safety and quality of medical device software25. The increase in battery safety specifications is likely a result of the growing number of portable medical devices containing built-in batteries26. Lastly, the heightened application of ISO 13485, an international standard related to medical device quality management system (QMS), reflects the increasing emphasis on the importance of medical device quality management. ISO 13485 has been fully adopted as a QMS standard in many countries since its revision in 201627.

Respiratory devices continue to be cleared by the FDA on an annual basis. In contrast, no FDA clearances have been issued since 2011 for devices that analyze only sleep-related parameters, and we observed a growing number of FDA-cleared products that analyze both sleep and respiration. Results from clinical trials for devices analyzing respiration and those focused on sleep are reported in 17 out of 28 (60.7%) and 9 out of 28 (32.1%) reports, respectively. This proportion is significantly higher than that of clinical trials for devices without specified parameters, which are described in 4 out of 28 reports (14.3%). This suggests that validation through clinical trials is common when presenting analyses related to respiration or sleep. Regarding the analysis of specific parameters in the sleep category, seven out of nine cases focused on the sleep stage as the primary parameter. AHI emerged as the most frequently analyzed parameter (9 out of 17) in the respiratory category. However, in recent years, the analysis of parameters has expanded to include additional indices, encompassing the respiratory effort index, oxygen desaturation index, and respiration disturbance index. This reflects ongoing efforts to address the recognized limitations of AHI in determining OSA severity28. Smaller trials, typically involving 10–30 patients, were the predominant trend. A temporary surge in the number of patients was observed during COVID-19; however, generalizing from this data proves challenging. The overall number of NCTs was limited and caused difficulties in discerning overarching trends; nevertheless, their proportion has remained stable since their inception in 2014.

The development of HSATs is expected to continue to grow in the future. However, ensuring consistency and homogeneity in the process (from device design to validation) to ensure sufficient safety and clinical effectiveness as a medical device remains challenging. The examples of FDA clearances reveal that HSATs are at least as safe as they should be as medical devices through compliance with standards for electrical safety and other safety-related contents. However, the examples exhibited a broad variation in compliance and documentation between manufacturers and devices. As HSATs are designed for use both in and out of the hospital, adherence to relevant standards for data storage, report generation, and communication with electronic health records is crucial. Although not addressed in this study, the European Union Medical Device Regulation (MDR)—particularly articles 109 and 110 related to confidentiality and data protection—offers a framework for compliance29. However, these acts lack detailed implementation instructions, indicating a need for clearer regulatory guidance for manufacturers. Furthermore, the lack of an established process is true for clinical trials. Disclosures about clinical trials are becoming more specific; however, no clear criteria exist for objectively assessing whether a minimum level of clinical effectiveness has been achieved, which can lead to manufacturer-specific or product-specific variations in clinical confidence. We believe that guidances for HSAT development and licensure would aid in ensuring its minimum safety and clinical effectiveness, which could include specifications that each type of HSAT must meet, clinical trial designs, and performance evaluation criteria to demonstrate effectiveness.

Comprehensively, HSATs adhere to the conventional clearance pathway for medical devices, yet no clearance guidances exist that are uniquely tailored to HSATs. The absence of specialized guidances results in a scenario wherein, even for HSATs that have obtained clearance from the FDA, the evidence supporting their performance or clinical validity often remains nebulous. This ambiguity can engender a diminution of trust in HSATs. To rectify these issues, it is of paramount importance for regulatory agencies responsible for the licensing of medical devices to establish and enforce comprehensive standards and guidances for clinical trials, thereby ensuring the robust validation of HSAT performance. The HSAT guidances are expected to play an important role in establishing standardized procedures, ensuring quality, prioritizing patient safety, maintaining consistency of interpretation, meeting ethical considerations, and facilitating evidence-based commercialization of home sleep studies.

Some points must be considered before generalizing the results of this study. First, the objective of this research was to assess the contemporary landscape based on analyses of reports submitted for FDA clearance. It is crucial to recognize that our critical observations were confined to documents that had received FDA clearance, given that regulatory bodies, apart from the FDA, do not universally disclose their certification reports. A major limitation of this study is its exclusion of devices that have obtained the CE mark, which serves as a fundamental criterion for the approval of medical devices in numerous countries that operate outside the FDA’s jurisdiction. This omission is particularly relevant given that (since 2017) devices bearing the CE mark have been regulated based on the MDR, which has not been reflected in our analysis. This could potentially introduce a bias toward conditions approved by the FDA. Therefore, when applying these results to a global context, a degree of caution is warranted to avoid overgeneralization, as our findings may not fully encapsulate the nuances of international regulatory frameworks. Second, reports for FDA clearance are voluntarily prepared and submitted by the manufacturer. In some cases, there may be practices undertaken by the manufacturer that are not documented in these reports. Therefore, the results of this study should be interpreted as indicative trends rather than findings aiming to provide a comprehensive depiction of all actions taken by manufacturers for FDA clearance. Third, for HSATs that operate in innovative ways, the Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory (SCOPER) categorization of HSATs based on the physiological signals measured and the methods of measurement may be more effective in structurally assessing the adequacy of device safety as well as clinical trials30. However, as the SCOPER categorization requires very specific information about the product (e.g., number of channels, sampling frequency), which is not available in FDA documents or manufacturer manuals and is only available in journal articles for a small number of products, this study did not include an analysis of HSATs according to the SCOPER categorization. Finally, we found missing information within the NCT documents during our efforts to summarize the clinical trial information. We have marked these data as “not specified;” however, caution should be exercised during additional interpretations.

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