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Related Experiment Video

Updated: Jun 26, 2025

Multi-Modal Home Sleep Monitoring in Older Adults

Multi-Modal Home Sleep Monitoring in Older Adults

Published on: January 26, 2019

FDA-cleared home sleep apnea testing devices.

Ji Hyeun Park¹, Changwon Wang², Hangsik Shin³

¹Department of Convergence Medicine, Asan Medical Center, Brain Korea 21 Project, University of Ulsan College of Medicine, Seoul, 05505, Republic of Korea.

NPJ Digital Medicine

|May 13, 2024

Summary

This summary is machine-generated.

Home sleep apnea testing (HSAT) device approvals surged post-pandemic, highlighting the need for standardized FDA processes. Clinical trials are crucial for ensuring the safety and effectiveness of these vital diagnostic tools.

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Area of Science:

Medical Devices
Sleep Medicine
Regulatory Science

Background:

Home sleep apnea testing (HSAT) device demand increased significantly, especially during the COVID-19 pandemic.
Lack of standardized development and verification procedures presents a major challenge for HSAT devices.
Ensuring safety and clinical effectiveness of HSAT devices is paramount for patient care.

Purpose of the Study:

To analyze the U.S. Food and Drug Administration (FDA) approval process characteristics for HSAT devices.
To evaluate trends in HSAT device clearances from 2003 to 2023, focusing on safety and effectiveness.
To identify key considerations for the development and regulatory review of HSAT devices.

Main Methods:

Analysis of 58 FDA clearance reports (510(k) and de novo pathways) for HSAT devices out of 1046 applications.
Examination of device types, measurement parameters, and adherence to safety standards.
Review of critical considerations including performance, usability, and cybersecurity.

Main Results:

A notable increase in HSAT device certifications was observed after 2022.
Type-3 devices, used for both home and clinical settings, were predominant.
Most FDA-cleared devices met electrical safety and biocompatibility standards, with respiration and sleep analysis (AHI, sleep stage) being key metrics.

Conclusions:

Clinical trials play an essential role in validating the effectiveness of HSAT devices.
Future research should focus on developing guidelines for stringent requirements, robust clinical trial designs, and comprehensive performance criteria.
Standardized regulatory pathways are needed to guarantee the minimum safety and clinical effectiveness of HSAT devices.