Sleepiz One+
Overview
Sleepiz One+ is an FDA-cleared, contactless remote patient monitoring device that utilizes radar technology to collect biometric data and record vital signs from a patient’s bedside. It provides comprehensive respiration and heart rate monitoring for chronic conditions, including sleep apnea screening. The device is designed for ease of use, allowing for quick installation and seamless data transmission via a cellular module. It measures macro and micro-motions from heart contractions and breathing patterns with medical-grade accuracy, transforming these signals into actionable data using proprietary AI. Sleepiz One+ aims to provide patient-centric disease management through seamless integration of contactless monitoring into people’s homes, offering an alternative to traditional, often cumbersome, diagnostic methods like polysomnography. It is intended for use by healthcare professionals in clinical settings or by patients and their caregivers in a home environment.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Contactless monitoring (radar technology)
- Measures respiration rate
- Measures heart rate
- Sleep apnea screening
- Remote patient monitoring
- AI-powered data analysis
- Web application for data access and analysis
- Easy setup and deployment
- Clinically validated
- HIPAA compliant
Use Cases
- Long-term monitoring of chronic respiratory diseases
- Sleep apnea diagnosis and screening
- Early detection of patient deterioration
- Hospital at Home programs
- Clinical trials and research studies
- Senior care and assisted living facilities
What Physicians Need to Know
Sleepiz One+ offers a valuable tool for contactless, long-term monitoring of heart rate and respiration rate, particularly beneficial for remote patient monitoring and clinical studies. Its high accuracy in vital sign measurement can aid in the early detection of physiological deterioration. Physicians should note that while it provides continuous data for review, it is not designed for real-time alarming in acute, life-threatening situations. It can be particularly useful for patients with chronic conditions, including cardiovascular and respiratory diseases, to track disease progression or remission and enable timely interventions.
The Sleepiz One+ seamlessly integrates into Remote Patient Monitoring (RPM) and clinical study platforms, providing healthcare professionals with access to comprehensive respiration and heart rate monitoring capabilities. Data is accessible via the Sleepiz cloud software for retrospective review and patient management. The device can also optionally integrate with additional Bluetooth devices, such as SpO2 sensors, to enhance monitoring capabilities.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
Contact for pricing
|
| Deployment | Wall-mounted or bedside table placement, Wi-Fi connectivity |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Sleepiz One+ received FDA Class II 510(k) clearance in October 2023. This clearance allows physicians to prescribe the device for monitoring vital signs and sleep apnea screening in adult patients. |
| Integrations | |
| EHR | Not specified |
| Specialties | Geriatrics, Pulmonology, Sleep Medicine |
What the Web Says
The Sleepiz One+ is a contactless remote patient monitoring device that has received FDA 510(k) clearance and CE mark certification. It uses radar technology to measure vital signs like heart rate and respiration rate, as well as detect sleep patterns and bed presence, without requiring any wearables. The device is designed for home use and aims to provide a more comfortable and less intrusive alternative to traditional sleep monitoring methods.
Overall: PositiveStrengths
- Contactless and non-invasive, improving patient comfort and compliance.
- Accurate in measuring breathing rate (99%) and heart rate (96%) compared to gold standard methods.
- Valid diagnostic tool for moderate to severe Obstructive Sleep Apnea (OSA), especially with an added SpO2 sensor.
- Easy to install and use, with a plug-and-play system and automatic cellular data transmission.
- Enables long-term, continuous monitoring of vital signs at home, providing comprehensive data for healthcare professionals.
- Facilitates remote patient monitoring and can be reimbursed by physicians using CPT codes.
Limitations
- Some users expressed concerns about data protection and being technically challenged.
- The ability to self-check device functionality was noted as missing in early testing.
- Fear of tripping over the device at night and its perceived inconvenience during the day were mentioned.
- Comprehensibility of the report could be improved with more text and explanation.
- May slightly underestimate AHI when an SpO2 sensor is added.
- Still struggles to distinguish between sleep and wakefulness, which is essential for accurate AHI estimation.
Based on reviews from: Sleepiz.com, PMC, Xtalks, ResearchGate, PubMed, Galaxus, Karger Publishers
Last updated: 2026-07-02
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