Huxley SANSA Home Sleep Apnea Test (1000-00)
Overview
The Huxley SANSA Home Sleep Apnea Test (1000-00) is an innovative, FDA-cleared wearable patch designed to simplify and enhance the diagnosis of sleep-related breathing disorders, particularly Obstructive Sleep Apnea (OSA), and comorbid cardiac arrhythmias. This single-point-of-skin-contact device eliminates the need for cumbersome wires, belts, or hoses, offering an app-free workflow with built-in cellular data upload for seamless transmission of results to healthcare providers.
SANSA utilizes advanced signal processing and AI-powered auto-scoring algorithms to analyze nine physiological data channels, including blood oxygen saturation (SpO2), ECG-derived heart rate, respiratory effort, chest movement, sleep staging (sleep/wake), snoring, body position, and actigraphy. It provides comprehensive insights into sleep health and cardiac rhythms, enabling physicians to make more informed diagnoses and treatment plans.
Validated in multi-site clinical trials, SANSA has demonstrated high accuracy, sensitivity, and specificity comparable to in-laboratory polysomnography (PSG) for detecting mild, moderate, and severe OSA. The device is intended for clinical and home use under the direction of a Healthcare Professional (HCP) and is available by prescription only.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Wearable chest patch design
- App-free workflow
- Built-in cellular data upload
- AI-powered auto-scoring algorithms
- 9 physiological data channels (ECG, SpO2, Heart Rate, Respiratory Effort, Chest Movement, Body Position, Actigraphy, Snoring, Sleep/Wake Staging)
- Multi-day monitoring capability
- Comfortable and non-invasive
- Validated against polysomnography (PSG)
- Streamlined diagnostic process for HCPs
- Secure end-to-end encryption
Use Cases
- Diagnosis of Obstructive Sleep Apnea (OSA)
- Detection of cardiac arrhythmias (e.g., atrial fibrillation) during sleep
- Remote patient monitoring for sleep and cardiac health
- Streamlining diagnostic workflows for sleep and cardiology practices
- Reducing patient referral processes and clinic visits
- Improving access to sleep apnea diagnosis
What Physicians Need to Know
The Huxley SANSA Home Sleep Apnea Test offers a unique advantage by combining sleep apnea diagnosis with diagnostic ECG monitoring for arrhythmias, such as atrial fibrillation, in a single, easy-to-use chest patch. This can streamline the diagnostic process for patients with co-existing sleep and cardiac conditions, reducing the need for multiple separate tests. Physicians should note that while the device provides actionable ECG strips for cardiac insights, the ECG data requires manual annotation and analysis. It is a valuable tool for identifying cardiac comorbidities in sleep apnea patients and can aid in initiating guideline-directed care more efficiently. The device's simplicity and cellular data upload improve patient compliance and data reliability.
The SANSA device integrates multiple physiological sensors (PPG, single-lead ECG, accelerometer) into a single-point-of-contact patch, eliminating external wires or attachments. Its advanced signal processing and AI/ML components analyze the collected data to generate comprehensive reports. The latest iteration includes built-in cellular connectivity for automatic data upload, ensuring secure and near real-time transmission of results to the Huxley HUBu2122 portal for physician review, without requiring patient interaction with a smartphone or Bluetooth.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Contact for pricing |
| Deployment | Cloud-based algorithm with cellular data upload from device |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Huxley Medical's SANSA Home Sleep Apnea Test (K240285) received 510(k) clearance from the FDA on July 15, 2024, for the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders in adults suspected of sleep apnea. Subsequent clearances have expanded its capabilities to include diagnostic ECG monitoring for cardiac arrhythmias. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Pulmonology, Sleep Medicine |
What the Web Says
The Huxley SANSA Home Sleep Apnea Test (1000-00) is an FDA-cleared, chest-worn patch designed for at-home diagnosis of sleep apnea, including obstructive and central sleep apnea, and now also functions as a diagnostic ECG monitor for cardiac arrhythmias. It aims to simplify the testing process by consolidating multiple physiological monitoring channels into a single, wireless device, eliminating the need for numerous wires, belts, or smartphone apps. Clinical studies have shown its performance to be comparable to in-laboratory polysomnography (PSG), the gold standard for sleep apnea diagnosis.
Overall: PositiveStrengths
- FDA-cleared for obstructive and central sleep apnea detection, and diagnostic ECG monitoring.
- Single, chest-worn patch design simplifies application and improves patient comfort and compliance.
- Wireless and uses cellular data upload, eliminating the need for multiple wires, tubing, or smartphone apps, and reducing connectivity issues.
- Provides comprehensive data, measuring eight to nine physiological channels, including blood oxygen saturation, heart rate, respiratory effort, and sleep staging.
- Demonstrated high accuracy, sensitivity, and specificity in detecting sleep apnea compared to in-lab PSG.
- Effective performance across all skin tones, addressing a previous challenge in sleep testing devices.
Limitations
- Some Reddit users expressed concern about the device being single-use and disposable, questioning the environmental impact and potential for waste.
- While generally accurate, one Reddit user reported a home test showing no sleep apnea, but a subsequent in-lab study diagnosed severe sleep apnea.
- The process can be impersonal for those desiring more interaction with a healthcare provider.
- Specificity for detecting sleep apnea can decrease at lower AHI cutoffs.
- Home sleep tests are generally only clinically appropriate for patients who meet specific pre-test criteria.
- Automated algorithms process SANSA data without technologist review, unlike the manual scoring of PSG studies.
Based on reviews from: Huxley Medical (SANSA by Huxley), Patient Care Online, Frontiers in Neurology (via PMC - NIH), SleepWorld Magazine, Respiratory Therapy, Reddit, Xtalks, accessdata.fda.gov, DAIC, YouTube, Sleep Review (Home Sleep Test Devices Comparison Guide)
Last updated: 2026-07-18
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